Biological indicator with variable resistance

ABSTRACT

A biological indicator with variable resistance may be controlled by moving a cap or housing of the biological indicator to cause the size of vents that allow flow of sterilant through the housing to decrease or increase in effective size. An indicator window may show a user the current resistance of the biological indicator, and may also show a readable indicator that may be captured by a scanner to allow a sterilizing cabinet to identify the current resistance. When the level of resistance shown by the readable indicator is not compatible with a sterilization cycle selected by a user, the procedure may be delayed and a notification provided to the user that a problem exists. The readable indicator may be a passive tag with a memory that allows information to be read and written, so that the biological indicator may carry data from one device to another.

BACKGROUND

Re-usable medical devices such as certain surgical instruments,endoscopes, etc., may be sterilized before re-use in order to minimizethe likelihood that a contaminated device might be used on a patient,which could cause an infection in the patient. Various sterilizationtechniques may be employed, such as steam, hydrogen peroxide, peraceticacid, and vapor phase sterilization, either with or without a gas plasmaand ethylene oxide (EtO). Each of these methods may depend to a certainextent on the diffusion rates of the sterilization fluids (e.g., gases)upon or into the medical devices to be sterilized.

Before sterilization, medical devices may be packaged within containersor pouches having a semi-permeable barrier that allows transmission ofthe sterilizing fluid—sometimes referred to as a sterilant—but preventsadmission of contaminating organisms, particularly post-sterilizationand until the package is opened by medical personnel. For thesterilization cycle to be efficacious, the contaminating organismswithin the package must be killed because any organisms that survive thesterilization cycle could multiply and re-contaminate the medicaldevice. Diffusion of the sterilant may be particularly problematic formedical devices that have diffusion-restricted spaces therein becausethese diffusion-restricted spaces may reduce the likelihood that asterilization cycle may be effective. For example, some endoscopes haveone or more long narrow lumens into which the sterilant must diffuse insufficient concentration for sufficient time to achieve a successfulsterilization cycle.

Sterilization of medical devices may be performed with an automatedsterilization system such as a STERRAD® System by Advanced SterilizationProducts of Irvine, Calif. Examples of automated sterilization systemsare described in U.S. Pat. No. 6,939,519, entitled “Power System forSterilization Systems Employing Low Frequency Plasma,” issued Sep. 6,2005, the disclosure of which is incorporated by reference herein; U.S.Pat. No. 6,852,279, entitled “Sterilization with Temperature-ControlledDiffusion Path,” issued Feb. 8, 2005, the disclosure of which isincorporated by reference herein; U.S. Pat. No. 6,852,277, entitled“Sterilization System Employing a Switching Module Adapter to Pulsatethe Low Frequency Power Applied to a Plasma,” issued Feb. 8, 2005, thedisclosure of which is incorporated by reference herein; U.S. Pat. No.6,447,719, entitled “Power System for Sterilization Systems EmployingLow Frequency Plasma,” issued Sep. 10, 2002, the disclosure of which isincorporated by reference herein; and U.S. Provisional Pat. App. No.62/316,722, entitled “System and Method for Sterilizing MedicalDevices,” filed Apr. 1, 2016, the disclosure of which is incorporated byreference herein.

Operator error may result in medical devices that are erroneouslybelieved to be decontaminated being returned to service. Confirming thata sterilization cycle has been efficacious may help medical personnelavoid using a contaminated medical device on a patient. The sterilizedmedical device might not itself be checked for contaminating organismsbecause such an activity may introduce other contaminating organisms tothe medical device, thereby re-contaminating it. Thus, an indirect checkmay be performed using a sterilization indicator. A sterilizationindicator is a device that may be placed alongside or in proximity to amedical device being subject to a sterilization cycle, such that thesterilization indicator is subject to the same sterilization cycle asthe medical device. For instance, a biological indictor having apredetermined quantity of microorganisms may be placed into asterilization chamber alongside a medical device and subject to asterilization cycle. After the cycle is complete, the microorganisms inthe biological indicator may be cultured to determine whether any of themicroorganisms survived the cycle. The presence or absence of livingmicroorganisms in the biological indicator will indicate whether thesterilization cycle was effective.

In view of the foregoing, it may be desirable to provide a sterilizationsystem that minimizes opportunities for operator error, therebymaximizing the likelihood of successful sterilization cycles, therebyminimizing the risk of patient infection. While a variety of systems andmethods have been made and used for medical device sterilization, it isbelieved that no one prior to the inventor(s) has made or used thetechnology as described herein.

BRIEF DESCRIPTION OF THE DRAWINGS

It is believed the present invention will be better understood from thefollowing description of certain examples taken in conjunction with theaccompanying drawings, in which like reference numerals identify thesame elements and in which:

FIG. 1 depicts a schematic view of an exemplary medical devicesterilizing cabinet;

FIG. 2 depicts a high level flowchart of an exemplary set of steps thata sterilizing cabinet of the system of FIG. 1 could perform to sterilizea medical device;

FIG. 3 depicts a flowchart of an exemplary set of steps that may becarried out as part of a sterilization cycle within the set of steps ofFIG. 2;

FIG. 4 depicts a schematic view of an exemplary biological indicatorassembly that may be placed with a medical device in the sterilizingcabinet of FIG. 1;

FIG. 5 depicts a schematic view of an exemplary indicator analyzer thatmay be used to process the biological indicator assembly of FIG. 4 afterthe biological indicator assembly has undergone a sterilization cycle inthe sterilizing cabinet of FIG. 1;

FIG. 6 depicts a flowchart showing an exemplary set of steps that may beperformed by a user of the indicator analyzer of FIG. 5 in preparationfor analysis of the biological indicator assembly of FIG. 4;

FIG. 7A depicts a side elevational view of an exemplary alternativebiological indicator assembly of FIG. 4 that may be used to perform anyof the methods of FIGS. 9-13, with the biological indicator assembly ina first state;

FIG. 7B depicts a side elevational view of the biological indicatorassembly of FIG. 7A, with the biological indicator assembly in a secondstate;

FIG. 8A depicts a top plan view of another exemplary alternativebiological indicator assembly of FIG. 4 that may be used to perform anyof the methods of FIGS. 9-13, with the biological indicator assembly ina first state;

FIG. 8B depicts a top plan view of the biological indicator assembly ofFIG. 8A, with the biological indicator assembly in a second state;

FIG. 8C depicts a top plan view of the biological indicator assembly ofFIG. 8A, with the biological indicator assembly in a third state;

FIG. 9 depicts a flowchart showing an exemplary set of steps that may beperformed using a modified version of the sterilizing cabinet of FIG. 1,using a modified version of the indicator analyzer of FIG. 5, and usinga modified version of the biological indicator assembly of FIG. 4;

FIG. 10 depicts a flowchart of another exemplary set of steps that maybe performed using a modified version of the sterilizing cabinet of FIG.1, using a modified version of the indicator analyzer of FIG. 5, andusing a modified version of the biological indicator assembly of FIG. 4;

FIG. 11 depicts a flowchart of another exemplary set of steps that maybe performed using a modified version of the sterilizing cabinet of FIG.1, using a modified version of the indicator analyzer of FIG. 5, andusing a modified version of the biological indicator assembly of FIG. 4;

FIG. 12 depicts a flowchart of another exemplary set of steps that maybe performed using a modified version of the sterilizing cabinet of FIG.1, using a modified version of the indicator analyzer of FIG. 5, andusing a modified version of the biological indicator assembly of FIG. 4;and

FIG. 13 depicts a flowchart of another exemplary set of steps that maybe performed using a modified version of the sterilizing cabinet of FIG.1, using a modified version of the indicator analyzer of FIG. 5, andusing a modified version of the biological indicator assembly of FIG. 4.

DETAILED DESCRIPTION

The following description of certain examples of the technology shouldnot be used to limit its scope. Other examples, features, aspects,embodiments, and advantages of the technology will become apparent tothose skilled in the art from the following description, which is by wayof illustration, one of the best modes contemplated for carrying out thetechnology. As will be realized, the technology described herein iscapable of other different and obvious aspects, all without departingfrom the technology. Accordingly, the drawings and descriptions shouldbe regarded as illustrative in nature and not restrictive.

It is further understood that any one or more of the teachings,expressions, embodiments, examples, etc. described herein may becombined with any one or more of the other teachings, expressions,embodiments, examples, etc. that are described herein. Thefollowing-described teachings, expressions, embodiments, examples, etc.should therefore not be viewed in isolation relative to each other.Various suitable ways in which the teachings herein may be combined willbe readily apparent to those of ordinary skill in the art in view of theteachings herein. Such modifications and variations are intended to beincluded within the scope of the claims.

I. OVERVIEW OF EXEMPLARY STERILIZATION SYSTEM

FIG. 1 depicts an exemplary sterilizing cabinet (150) that is operableto sterilize medical devices such as endoscopes, etc. Sterilizingcabinet (150) of the present example includes a sterilization chamber(152), which is configured to receive one or more medical devices forsterilization. While not shown, sterilizing cabinet (150) also includesa door that opens and closes sterilization chamber (152) in response toactuation of a kick plate. An operator may thereby open and closesterilization chamber (152) in a hands-free fashion. Of course, anyother suitable features may be used to provide selective access tosterilization chamber. Sterilizing cabinet (150) also includes asterilization module (156) that is operable to dispense a sterilant intosterilization chamber (152) in order to sterilize medical devicescontained in sterilization chamber (152). In the present example,sterilization module (156) is configured to receive replaceablesterilant cartridges (158) containing a certain amount of sterilant. Byway of example only, each sterilant cartridge (158) may contain enoughsterilant to perform five sterilization procedures.

In the present example, sterilization module (156) is operable to applya sterilant in the form of a vapor within sterilization chamber (152).By way of example only, sterilization module (156) may comprise acombination of a vaporizer and a condenser. The vaporizer may include achamber that receives a particular concentration of sterilant solution(e.g., a liquid hydrogen peroxide solution with a concentration ofapproximately 59% nominal, or between approximately 58% andapproximately 59.6%); where the sterilant solution changes phase fromliquid to vapor. The condenser may provide condensation of the sterilantsolution vapor, and the concentration of the sterilant solution may bethereby increased (e.g., from approximately 59% nominal to somewherebetween approximately 83% nominal and approximately 95% nominal), byremoval of water vapor. Alternatively, any other suitable methods andcomponents may be used to apply sterilant in the form of a vapor withinsterilization chamber (152). In any case, to supplement the applicationof the sterilant in the form of a vapor, the sterilant may also beapplied (in liquid form) to the inside of lumen(s) and/or other internalspaces within the medical device and/or the outside of the medicaldevice, before the medical device is placed in sterilization chamber(152). In such versions, the sterilant may evaporate while a vacuum isapplied to sterilization chamber (152) (e.g., as described in greaterdetail below with reference to block 310 of FIG. 3) and even aftervacuum is applied; and provide more concentration of sterilant to theareas of the medical device with less penetration range, thereby furtherpromoting effective sterilization.

Sterilizing cabinet (150) of the present example further includes atouch screen display (160). Touch screen display (160) is operable torender the various user interface display screens, such as thosedescribed in U.S. Provisional Pat. App. No. 62/316,722, the disclosureof which is incorporated by reference herein. Of course, touch screendisplay (160) may display various other screens as well. Touch screendisplay (160) is further configured to receive user input in the form ofthe user contacting touch screen display (160) in accordance withconventional touch screen technology. In addition, or in thealternative, sterilizing cabinet (150) may include various other kindsof user input features, including but not limited to buttons, keypads,keyboards, a mouse, a trackball, etc.

Sterilizing cabinet (150) of the present example further includes aprocessor (162), which is in communication with sterilization module(156) and with touch screen display (160). Processor (162) is operableto execute control algorithms to drive sterilization module (156) inaccordance with user input. Processor (162) is further operable toexecute instructions to display the various screens on touch screendisplay (160); and to process instructions received from a user viatouch screen display (160) (and/or via other user input features).Processor (162) is also in communication with various other componentsof sterilization cabinet (150) and is thereby operable to drive thosecomponents and/or process input and/or other data from those components.Various suitable components and configurations that may be used to formprocessor (162) will be apparent to those of ordinary skill in the artin view of the teachings herein.

Sterilizing cabinet (150) of the present example further includes acommunication module (154). Communication module (154) is configured toenable bidirectional communication between sterilizing cabinet (150) anda communication hub (not shown), a server, and/or other equipment. Insome versions, communication module (154) is configured to communicatewith a hub in accordance with at least some of the teachings of U.S.Patent App. No. 62/376,517, entitled “Apparatus and Method to LinkMedical Device Sterilization Equipment,” filed Aug. 18, 2016, thedisclosure of which is incorporated by reference herein. By way ofexample only, communication module (154) may be configured to providewired and/or wireless communication via as Ethernet, Wi-Fi, Bluetooth,USB, infrared, NFC, and/or other technologies. Various suitablecomponents and configurations that may be used to form communicationmodule (154) will be apparent to those of ordinary skill in the art inview of the teachings herein. Communications that are sent from orreceived through communication module (154) are processed throughprocessor (162).

Sterilizing cabinet (150) of the present example further includes anidentification tag reader (166), which is operable to read anidentification tag of a biological indicator as described herein. By wayof example only, identification tag reader (166) may comprise an opticalreader that is operable to read an optical identification tag (e.g.,barcode, data matrix code, QR code, etc.) of a biological indicator. Inaddition, or in the alternative, identification tag reader (166) maycomprise an RFID reader that is operable to read an RFID identificationtag of a biological indicator. In some versions where identification tagreader (166) comprises an RFID reader, identification tag reader (166)is also operable to write information to an RFID tag of a biologicalindicator. Various suitable components and configurations that may beused to form identification tag reader (166) will be apparent to thoseof ordinary skill in the art in view of the teachings herein. Datareceived through identification tag reader (166) is processed throughprocessor (162).

Sterilizing cabinet (150) of the present example further includes amemory (168), which is operable to store control logic and instructionsand that are executed by processor (162) to drive components such assterilization module (156), touch screen display (160), communicationmodule (154), and identification tag reader (166). Memory (168) may alsobe used to store results associated with setup of a sterilization cycle,performance of a load conditioning cycle, performance of a sterilizationcycle, and/or various other kinds of information. Various suitable formsthat memory (168) may take, as well as various ways in which memory(168) may be used, will be apparent to those of ordinary skill in theart in view of the teachings herein.

Sterilizing cabinet (150) of the present example further includes aprinter (170), which is operable to print information such as resultsassociated with setup of a sterilization cycle, performance of a loadconditioning cycle, performance of a sterilization cycle, and/or variousother kinds of information. By way of example only, printer (170) maycomprise a thermal printer, though of course any other suitable kind ofprinter may be used. Various suitable forms that printer (170) may take,as well as various ways in which printer (170) may be used, will beapparent to those of ordinary skill in the art in view of the teachingsherein. It should also be understood that printer (170) is merelyoptional and may be omitted in some versions.

Sterilizing cabinet (150) of the present example further includes avacuum source (180) and a venting valve (182). Vacuum source (180) is influid communication with sterilization chamber (152) and is also incommunication with processor (162). Thus, processor (162) is operable toselectively activate vacuum source (180) in accordance with one or morecontrol algorithms. When vacuum source (180) is activated, vacuum source(180) is operable to reduce the pressure within sterilization chamber(152) as will be described in greater detail below. Venting valve (182)is also in fluid communication with sterilization chamber (152). Inaddition, venting valve (182) is in communication with processor (162)such that processor (162) is operable to selectively activate ventingvalve (182) in accordance with one or more control algorithms. Whenventing valve (182) is activated, venting valve (182) is operable tovent sterilization chamber (152) to atmosphere as will be described ingreater detail below. Various suitable components that may be used toprovide vacuum source (180) and venting valve (182) will be apparent tothose of ordinary skill in the art in view of the teachings herein.

In addition to the foregoing, sterilizing cabinet (150) may beconfigured and operable in accordance with at least some of theteachings of U.S. Pat. No. 6,939,519, the disclosure of which isincorporated by reference herein; U.S. Pat. No. 6,852,279, thedisclosure of which is incorporated by reference herein; U.S. Pat. No.6,852,277, the disclosure of which is incorporated by reference herein;U.S. Pat. No. 6,447,719, the disclosure of which is incorporated byreference herein; U.S. Pat. No. 6,365,102, the disclosure of which isincorporated by reference herein; U.S. Pat. No. 6,325,972, thedisclosure of which is incorporated by reference herein; and/or U.S.Provisional Patent App. No. 62/316,722, the disclosure of which isincorporated by reference herein.

II. OVERVIEW OF EXEMPLARY STERILIZATION PROCESS

FIG. 2 depicts a high level flowchart of an exemplary set of steps thatsterilizing cabinet (150) could perform to sterilize a used medicaldevice, such as an endoscope. Sterilizing cabinet (150) may beconfigured to perform one or more sterilization cycles, with differentsterilization cycles being appropriate for different types andquantities of medical devices. Thus, as an initial step, sterilizingcabinet (150) may display one or more available sterilization cycles viatouch screen display (160) and then receive a sterilization cycleselection (block 200) from the user.

Sterilizing cabinet (150) may also display instructions indicatingwhether a biological indicator should be used with the selectedsterilization cycle, and receive a biological indicator identification(block 202). Such a biological indicator identification (block 202) maybe provided via identification tag reader (166), via touch screendisplay (160), or otherwise. A biological indicator may be placed insidesterilization chamber (152) of sterilizing cabinet (150) before thesterilization cycle begins and may remain in the sterilization chamberduring the sterilization cycle. The user may thus identify theparticular biological indicator (block 202) before the biologicalindicator is placed in the sterilization chamber. The biologicalindicator may contain microorganisms that are responsive to a particularsterilization cycle. Upon completion of the sterilization cycle, thebiological indicator may be tested for the microorganisms in order toprovide a measure of the effectiveness of the sterilization cycle. Abiological indicator may not necessarily be required for allsterilization cycles, but may be required based on hospital rules orlocal regulations.

Selection of a sterilization cycle (block 200) and identification of abiological indicator (block 202) may define one or more requirements forthe configuration and arrangement of medical devices withinsterilization chamber (152). Thus, in order to provide preparation forthe sterilization cycle (block 204) once the sterilization cycle hasbeen selected (block 200) and the biological indicator has beenidentified (block 202), sterilizing cabinet (150) may provide a displayvia touch screen display (160) indicating a proper medical deviceplacement. This display may serve as a visual guide to a user'splacement of medical device(s) (and perhaps a biological indicator)within sterilizing chamber (152) of sterilizing cabinet (150), based onthe sterilization cycle selection (block 200). A door of sterilizationchamber (152) may be opened to enable the user to place the medicaldevice(s) (and perhaps a biological indicator) within sterilizingchamber (152) as instructed.

Once the user has placed the medical device in sterilizing chamber (152)based on these instructions, the user may press a start button or otherbutton indicating that medical device placement is complete. In someversions, sterilizing cabinet (150) is configured to automaticallyverify proper medical device placement. By way of example only,sterilizing cabinet (150) may employ photo sensors, imaging devices,weight sensors, and/or other components to verify proper medical deviceplacement in sterilizing chamber (152). It should be understood,however, that some versions of sterilizing cabinet (150) may lack thecapability of automatically verifying proper placement of a medicaldevice within sterilizing chamber (152).

If medical device placement is verified and/or the user has otherwisecompleted the cycle preparation (block 204), sterilizing cabinet (150)may start a load conditioning process (block 206). The load conditioningprocess (block 206) prepares sterilization chamber (152) and the medicaldevice(s) within sterilization chamber (152) for optimal sterilizationduring a sterilization cycle. Conditioning may include controlling andoptimizing one or more characteristics of sterilization chamber (152).For example, during load conditioning, sterilizing cabinet (150) maycontinuously monitor the level of moisture within sterilization chamber(152) while reducing the level of moisture by, for example, circulatingand dehumidifying the air of sterilization chamber (152), creating avacuum within sterilization chamber (152), heating sterilization chamber(152), and/or other methods for dehumidifying a sealed chamber. This maycontinue until sterilizing cabinet (150) determines that an acceptablelevel of moisture has been reached.

As part of the load conditioning cycle (block 206), sterilizing cabinet(150) may also continuously detect the temperature within sterilizationchamber (152) while heating sterilization chamber (152) by, for example,convection of heated air, conduction through an interior surface ofsterilization chamber (152), and/or using other techniques. This maycontinue until sterilizing cabinet (150) determines that an acceptableinternal temperature has been reached. Various conditioning actions suchas controlling temperature or humidity may be performed in parallel orin sequence. It should also be understood that the load conditioningcycle (block 206) may verify that the sterilization chamber is sealed;verifying contents of the sterilization chamber; checking physicalcharacteristics of the contents of the sterilization chamber such ascontent volume, content weight, or other characteristics; and/orperforming one or more conditioning steps that may include chemicaltreatment, plasma treatment, or other types of treatment to reducemoisture, raise temperature, and/or otherwise prepare the medicaldevices in sterilization chamber (152) for the sterilization cycle(block 208).

While the one or more conditioning actions are being performed as partof the load conditioning cycle (block 206), sterilizing cabinet (150)may display information via touch screen display (160) indicating to auser the duration of time before the sterilization cycle (block 208)performance may begin. Once all load conditioning criteria have beensuccessfully met, the load conditioning cycle (block 206) is complete,and the sterilization cycle (block 208) may then be performed. It shouldtherefore be understood that sterilizing cabinet (150) is configuredsuch that the sterilization cycle (block 208) is not actually initiateduntil after the load conditioning cycle (block 206) is complete. Itshould also be understood that the load conditioning cycle (block 206)may be omitted or varied in some versions of sterilizing cabinet (150)operation.

As noted above, sterilization cabinet (150) may begin performing thesterilization cycle (block 208) automatically and immediately after loadconditioning (block 206) has been completed. The sterilization cycle(block 208) may include exposing the medical device(s) in thesterilizing chamber to pressurized sterilant gas, further heattreatment, chemical treatment, plasma treatment, vacuum treatment,and/or other types of sterilization procedures. During performance ofthe sterilization cycle (block 208), sterilization cabinet (150) maydisplay information via touch screen display (160) such as a durationremaining for the sterilization cycle (block 208), the current stage ofthe sterilization cycle (block 208) (e.g. plasma, vacuum, injection,heat, chemical treatment), and/or other information.

In some versions, the sterilization cycle (block 208) includes theexemplary sub-steps shown in FIG. 3. In particular, the cycle may beginwith a vacuum being applied (block 310) within sterilization chamber(152). In order to provide such a vacuum, processor (162) may activatevacuum source (180) in accordance with a control algorithm. Processor(162) will then determine (block 312) whether a sufficient pressurelevel has been reached within sterilization chamber (152). By way ofexample only, processor (162) may monitor data from one or more pressuresensors within sterilization chamber (152) as part of the determinationstep (block 312). Alternatively, processor (162) may simply activatevacuum source (180) for a predetermined time period and assume that theappropriate pressure has been reached in sterilization (152) based uponthe duration for which vacuum source (180) is activated. Other suitableways in which processor (162) may determine (block 312) whether asufficient pressure level has been reached within sterilization chamber(152) will be apparent to those of ordinary skill in the art in view ofthe teachings herein. Until the appropriate pressure level has beenreached within sterilization chamber (152), vacuum source (180) willremain activated.

Once sterilization chamber (152) reaches an appropriate pressure level(e.g., between approximately 0.2 torr and approximately 10 torr),processor (162) then activates sterilization module (156) to apply asterilant (block 314) in sterilization chamber (152). This stage of theprocess may be referred to as the “transfer phase.” By way of exampleonly, the sterilant may comprise a vapor of oxidizing agent such ashydrogen peroxide, peroxy acids (e.g. peracetic acid, performic acid,etc.), ozone, or a mixture thereof. Furthermore, the sterilant maycomprise chlorine dioxide. Various other suitable forms that thesterilant may take are described herein; while other forms will beapparent to those of ordinary skill in the art in view of the teachingsherein. It should also be understood that, in some versions, thesterilant may be applied (block 314) in different ways based on theuser's selection of cycle (block 200) as described above.

Once the sterilant has been applied (block 314) to sterilization chamber(152), processor (162) monitors the time (block 316) to determinewhether a sufficient, predetermined duration has passed. By way ofexample only, this predetermined duration may be anywhere from a fewseconds to several minutes. Until the predetermined duration has passed,sterilization chamber (152) remains in a sealed state at the above-notedpredetermined pressure level, with the applied sterilant acting upon themedical device(s) contained within sterilization chamber (152).

After the predetermined duration has passed, processor (162) activates(block 318) venting valve (182) to vent sterilization chamber (152) toatmosphere. In some versions, sterilization chamber (152) is allowed toreach atmospheric pressure, while in other versions sterilizationchamber (152) only reaches sub-atmospheric pressure. The venting stageof the process may be referred to as the “diffusion phase.” In thepresent example, the sterilization cycle is then complete (block 320)after completion of the diffusion phase. In some other instances, vacuumis again applied to sterilization chamber (152) after completion of thediffusion phase; and then a plasma is applied to sterilization chamber(152), It should be understood that the entire sterilization cycle shownin FIG. 3 (including the above-noted variation where a subsequent vacuumthen sterilization are applied) may be repeated one or more times afterbeing completed once. In other words, a medical device may remain withinsterilization chamber (152) and experience two or more iterations of theentire cycle shown in FIG. 3 (including the above-noted variation wherea subsequent vacuum then sterilization are applied). The number ofiterations may vary based on the cycle selection (block 200), which maybe influenced by the particular kind of medical device that is beingsterilized in sterilization chamber (152).

Upon completion of the sterilization cycle (block 208), sterilizationcabinet (150) may cycle the results (block 210) of the sterilizationcycle (block 208). For instance, if the sterilization cycle (block 208)was canceled or unable to complete due to error or by a user action,sterilizing cabinet (150) may remain sealed and may also display asterilization cycle cancellation message via touch screen display (160);as well as various details relating to the sterilization cycle, such asdate, time, configuration, elapsed time, sterilization cycle operator,the stage at which the sterilization cycle failed, and other informationthat may be used to identify why the sterilization cycle. If thesterilization cycle (block 208) is completed successfully, sterilizationcabinet (150) may display a notification via touch screen display (160)indicating successful completion of the sterilization cycle (block 208).In addition, sterilization cabinet (150) may display information such assterilization cycle identifier, sterilization cycle type, start time,duration, operator, and other information (666).

In some variations, a pre-plasma may be applied in the sterilizationcycle (block 208) to heat up the medical device contained insterilization chamber (152). By way of example only, plasma may beapplied between applying a vacuum (block 310) and applying sterilant(block 314). In addition, or in the alternative, a post-plasma may beapplied at the end of the sterilization cycle (block 208) to degrade anyresidual sterilant that may be adsorbed to the surface of the medicaldevice contained in sterilization chamber (152). It should be understoodthat, before applying the post-plasma, a vacuum would first need to beapplied to sterilization chamber (152).

By way of example only, the process depicted in FIG. 3 may be carriedout at temperatures where the walls of sterilization chamber (152) arebetween approximately 30° C. and approximately 56° C., or moreparticularly between approximately 47° C. and approximately 56° C., oreven more particularly approximately 50° C.; and where the temperatureof the medical device in sterilization chamber (152) is betweenapproximately 5-10° C. and approximately 40-55° C.

In addition to the foregoing, sterilizing cabinet (150) may beconfigured to perform sterilization processes in accordance with atleast some of the teachings of U.S. Pat. No. 6,939,519, the disclosureof which is incorporated by reference herein; U.S. Pat. No. 6,852,279,the disclosure of which is incorporated by reference herein; U.S. Pat.No. 6,852,277, the disclosure of which is incorporated by referenceherein; U.S. Pat. No. 6,447,719, the disclosure of which is incorporatedby reference herein; U.S. Pat. No. 6,365,102, the disclosure of which isincorporated by reference herein; U.S. Pat. No. 6,325,972, thedisclosure of which is incorporated by reference herein; and/or U.S.Provisional Patent App. No. 62/316,722, the disclosure of which isincorporated by reference herein.

While the foregoing examples are described in the context of sterilizingmedical devices, and particularly endoscopes, it should be understoodthat the teachings herein may also be readily applied in the context ofsterilizing various other kinds of articles. The teachings are notlimited to endoscopes or other medical devices. Other suitable articlesthat may be sterilized in accordance with the teachings herein will beapparent to those of ordinary skill in the art.

III. EXEMPLARY BIOLOGICAL INDICATOR ASSEMBLY

As noted above, a biological indicator may be included in sterilizingcabinet (150) along with the medical device during the sterilizationprocess (block 208) in order to ensure that the sterilization process(block 208) was successful. FIG. 4 shows an exemplary form that such abiological indicator may take. In particular, FIG. 4 shows a biologicalindicator (700) that includes a housing (710), a cap (720), an ampoule(730), and a carrier (740). Housing (710) is formed of a transparentmaterial (e.g., clear plastic, glass, etc.) and is hollow such thathousing (710) insertably receives ampoule (730). Ampoule (730) is alsoformed of a transparent material (e.g., clear plastic, glass, etc.) andcontains a fluid (732). By way of example only, fluid (732) may comprisea liquid growth medium. Such a liquid growth medium is capable of, withincubation, promoting growth of any viable microorganisms it contacts.Fluid (732) also includes a fluorophore whose fluorescence depends onthe amount of living microorganisms that may be contained in the liquidmedium of fluid (732) after ampoule (730) is fractured as will bedescribed in greater detail below. Fluid (732) is sealed within ampoule(730).

Carrier (740) provides a source of microorganisms or active enzymes. Byway of example only, carrier (740) may be impregnated with bacterialspores, other forms of bacteria (e.g., vegetative), and/or activeenzymes. By way of example only, spores from Bacillus, Geobacillus, andClostridium species may be used. Carrier (740) may be water-absorbentand may be formed of filter material. Sheet-like materials such ascloth, paper, nonwoven polypropylene, rayon or nylon, and microporouspolymeric materials may also be used to form carrier (740). Non-waterabsorbent materials may also be used to form carrier (740), such asmetals (e.g., aluminum or stainless steel), glass (e.g., glass beads orglass fibers), porcelain, or plastic. Of course, combinations of theforegoing materials may also be used to form carrier (740).

Ampoule (730) is configured as a frangible component of biologicalindicator (700), such that ampoule (730) may be fractured within housingto release fluid (732) in housing (710). To assist in the fracture ofampoule (730), a set of fracturing features (750) are disposed in thebottom of housing (710). While fracturing features (750) are shown asspikes in FIG. 4, it should be understood that this is merelyillustrative. Fracturing features (750) may take any other suitableform. To further assist in the fracture of ampoule (730), cap (720) isconfigured to slide downwardly along housing (710) to press ampoule(730) against fracturing features (750). This may be done right beforebiological indicator (700) is inserted into indicator analyzer (800) asdescribed in greater detail below. It should be understood that ampoule(730) would remain intact while biological indicator (700) is insterilizing cabinet (150) during a sterilization process. Cap (720) mayinclude one or more openings that allow gasses (e.g., air or sterilant,etc.) to pass into housing (710) before cap (720) is pressed downwardlyrelative to housing (710) to fracture ampoule (730). These openings maythus enable the microorganisms on carrier (740) to be destroyed by thesterilization process (block 208). However, after cap (720) is presseddownwardly relative to housing (710) to fracture ampoule (730), theseone or more openings may be sealed to contain the released fluid (732)in housing (710). When fluid (732) is released from ampoule (730), thereleased fluid eventually reaches carrier (740), thereby initiating anincubation process with any living microorganisms remaining on carrier(740).

While not shown in FIG. 4, housing (710) may also include anidentification tag. Such an identification tag may include a machinereadable feature that is capable of being read by identification tagreader (166) of sterilizing cabinet (150) and indicator analyzer (800).By way of example only, the identification tag may comprise an opticalcode (e.g., a barcode, a data matrix code, a QR code, etc.), an RFIDtag, and/or any other suitable kind of machine readable identifier. Inaddition, the identification tag may include human readable featuressuch as text, numbers, color coding, etc.

Cap (720) may also include a color changing feature. Such a colorchanging feature may serve as a chemical indicator that changes colorwhen biological indicator (700) is exposed to the sterilant ofsterilizing cabinet (150). In some versions, the color changing featuresimply changes between two distinctive colors, with one of the colorsindicating no exposure to a sterilant and the other color indicating atleast some exposure to a sterilant. In some other versions, the colorchanging feature changes along a range of colors based on the extent towhich biological indicator (700) has been exposed to a sterilant. Inother words, the color change may be proportional to the degree ofsterilant exposure. As yet another merely illustrative example, a colorchanging feature may change color (e.g., from one of two availablecolors to another of two available colors; or along a range of colors)in response to a combination of two or more parameters. For instance,such parameters may include (but need not be limited to) time andconcentration of sterilant; time, temperature, and concentration oramount/dose of sterilant received; and/or other parameters as will beapparent to those of ordinary skill in the art in view of the teachingsherein.

In addition to or in lieu of the foregoing, biological indicator (700)may be configured and operable in accordance with at least some of theteachings of U.S. patent application Ser. No. 15/057,768, entitled“Self-Contained Biological Indicator,” filed Mar. 1, 2016, thedisclosure of which is incorporated by reference herein. Other suitableforms that biological indicator (700) may take will be described belowor will be apparent to those of ordinary skill in the art in view of theteachings herein.

IV. EXEMPLARY BIOLOGICAL INDICATOR ANALYZER

A. Exemplary Biological Indicator Analyzer Hardware

FIG. 5 depicts an exemplary set of components that may be incorporatedinto biological indicator analyzer (800). In particular, FIG. 5 shows anexemplary biological indicator analyzer (800) that is operable toperform a biological indicator analysis. Biological indicator analyzer(800) of this example comprises a plurality of wells (810), each ofwhich is configured to insertingly receive a respective biologicalindicator (700). While two wells (810) are shown, it should beunderstood that any other suitable number of wells (810) may beprovided, including eight wells (810), less than eight wells (810), ormore than eight wells (810). Biological indicator analyzer (800) alsoincludes a processor (820) that is operable to execute instructions andcontrol algorithms, process information, etc.

Each well (810) has an associated light source (830) and sensor (840).Each light source (830) is configured to project light through housing(710) of the biological indicator (700) that is inserted in thecorresponding well (810); and each sensor (840) is operable to detectlight fluoresced by fluid (732) contained in housing (710). By way ofexample only, light source (830) may be in the form of a laser that isconfigured to emit ultraviolet light. Various other suitable forms thatlight source (830) may take will be apparent to those of ordinary skillin the art in view of the teachings herein. By way of further exampleonly, sensor (840) may comprise a charge coupled device (CCD). Variousother suitable forms that sensor (840) may take will be apparent tothose of ordinary skill in the art in view of the teachings herein. Asnoted above, the fluorescence of fluid (732) will depend on the amountof living microorganisms contained in the medium of fluid (732). Thus,sensor (840) will be able to detect the presence of livingmicroorganisms in fluid (732) based on the degree to which fluid (732)fluoresces in response to light from light source (830).

Biological indicator analyzer (800) of the present example furtherincludes a touch screen display (850). Touch screen display (850) isoperable to render various user interface display screens associatedwith operation of biological indicator analyzer (800). Touch screendisplay (850) is further configured to receive user input in the form ofthe user contacting touch screen display (850) in accordance withconventional touch screen technology. In addition, or in thealternative, biological indicator analyzer (800) may include variousother kinds of user input features, including but not limited tobuttons, keypads, keyboards, a mouse, a trackball, etc. Displaysprovided through touch screen display (850) may be driven by processor(820). User inputs received through touch screen display (850) may beprocessed by processor (820).

Biological indicator analyzer (800) of the present example furtherincludes a communication module (860). Communication module (860) isconfigured to enable bidirectional communication between biologicalindicator analyzer (800) and a communication hub (not shown), a server,and/or other equipment. In some versions, communication module (860) isconfigured to communicate with a hub in accordance with at least some ofthe teachings of U.S. Patent App. No. 62/376,517, entitled “Apparatusand Method to Link Medical Device Sterilization Equipment,” filed Aug.18, 2016, the disclosure of which is incorporated by reference herein.By way of example only, communication module (860) may be configured toprovide wired and/or wireless communication via as Ethernet, Wi-Fi,Bluetooth, USB, infrared, NFC, and/or other technologies. Varioussuitable components and configurations that may be used to formcommunication module (860) will be apparent to those of ordinary skillin the art in view of the teachings herein. Communications that are sentfrom or received through communication module (860) are processedthrough processor (820).

Biological indicator analyzer (800) of the present example furtherincludes an identification tag reader (870), which is operable to readan identification tag of biological indicator (700) as described herein.It should be understood that identification tag reader (870) may be usedto identify biological indicator (700) before biological indicator (700)is analyzed. By way of example only, identification tag reader (870) maycomprise an optical reader that is operable to read an opticalidentification tag (e.g., barcode, data matrix code, QR code, etc.) of abiological indicator (700). In addition, or in the alternative,identification tag reader (870) may comprise an RFID reader that isoperable to read an RFID identification tag of a biological indicator(700). In some versions where identification tag reader (870) comprisesan RFID reader, identification tag reader (870) is also operable towrite information to an RFID tag of a biological indicator (700).Various suitable components and configurations that may be used to formidentification tag reader (870) will be apparent to those of ordinaryskill in the art in view of the teachings herein. Data received throughidentification tag reader (870) is processed through processor (820).

Biological indicator analyzer (800) of the present example furtherincludes a memory (880), which is operable to store control logic andinstructions and that are executed by processor (820) to drivecomponents such as light source (830), touch screen display (850),communication module (860), and identification tag reader (870). Memory(880) may also be used to store results associated with performance ofbiological indicator analysis, and/or various other kinds ofinformation. Various suitable forms that memory (880) may take, as wellas various ways in which memory (880) may be used, will be apparent tothose of ordinary skill in the art in view of the teachings herein.

B. Exemplary Biological Indicator Processes and Interfaces

FIG. 6 shows an exemplary set of steps that may be used to initiatebiological indicator (700) analysis cycle by biological indicatoranalyzer (800). As a first step, the user may observe which wells (810)are vacant (block 900) and select a vacant well (block 902). In someversions, touch screen display (850) presents a number next to eachvacant well (810), such that the operator simply touches the numberassociated with the selected vacant well (810) in order to effectselection of that vacant well (block 902). Next, a display screen ontouch screen display (850) may prompt the user to place theidentification tag of biological indicator (700) near identification tagreader (870) to enable identification tag reader (870) to read theidentification tag of biological indicator (700). As part of thisprompting, touch screen display (850) may point to the location ofidentification tag reader (870) to assist the user in findingidentification tag reader (870). The user may then use identificationtag reader (870) to read the identification tag of biological indicator(700) (block 904).

A display screen on touch screen display (850) may then prompt the userto identify himself or herself. The user may then manipulate touchscreen display (850) to identify himself or herself (block 906). Adisplay screen on touch screen display (850) may then prompt the user toindicate whether the chemical indicator on cap (720) of biologicalindicator (700) has changed color. The user may then manipulate touchscreen display (850) to indicate whether the chemical indicator on cap(720) of biological indicator (700) has changed color (block 908).

A display screen on touch screen display (850) may then prompt the userto prepare biological indicator (700) for loading into the selected well(810) by fracturing ampoule (730) and agitating biological indicator(700). The operator may then fracture ampoule (730) by pressing on cap(720), then agitate biological indicator (700) (block 910) to ensureproper mixing of fluid (732) with carrier (740). The user may thenquickly place biological indicator (700) in the selected well (810)(block 912). In some instances, it may be desirable to insert biologicalindicator (700) in the selected well (810) (block 912) immediately afterfracturing ampoule (730) and agitating biological indicator (700) (block910).

In some versions, indicator analyzer (800) is configured to determinewhether the user appropriately completed the step of fracturing ampoule(730) and agitating biological indicator (700) (block 910) beforeinserting biological indicator (700) in the selected well (810) (block912). By way of example only, this may be determined based on how sensor(840) detects light emitted by light source (830) after biologicalindicator (700) is inserted in the selected well (810). In the eventthat indicator analyzer (800) determines that the user failed toappropriately complete the step of fracturing ampoule (730) andagitating biological indicator (700) (block 910) before insertingbiological indicator (700) in the selected well (810) (block 912), touchscreen display (850) may prompt the user to withdraw biologicalindicator (700) from well (810) and properly complete the step offracturing ampoule (730) and agitating biological indicator (700) (block910).

To the extent that the user has properly completed the step offracturing ampoule (730) and agitating biological indicator (700) (block910), and then inserted biological indicator (700) in the selected well(block 912), biological indicator (700) is allowed to sit in well (810)for an incubation period (block 914). During the incubation period(block 914), light source (830) associated with the selected well (810)is activated and sensor (840) monitors responsive fluorescence of fluid(732) in indicator (700). Well (810) may also be heated (e.g., toapproximately 60° C.) during the incubation period (block 914). As notedabove, fluid (732) includes a fluorophore whose fluorescence depends onthe amount of microorganisms contained in the medium. Thus, sensor (840)can detect the presence of living microorganisms (from carrier (740)) influid (732) based on the fluorescence of fluid (732). It shouldtherefore be understood that, after a suitable incubation period haspassed, indicator analyzer (800) will conclude whether any of themicroorganisms that were on carrier (740) (i.e., before thesterilization cycle in sterilization cabinet (150)) survived thesterilization cycle in sterilization cabinet (150), based on thefluorescence of fluid (732) as sensed by sensor (840).

By way of example only, the incubation period (block 914) may beapproximately 30 minutes. Alternatively, the incubation period may besubstantially longer (e.g., one or more hours), shorter, or of any othersuitable duration. During the incubation period (block 914), touchscreen display (850) may provide a graphical representation of theamount of time remaining in the incubation period. When more than onewell (810) is occupied by a corresponding biological indicator (700),touch screen display (850) may provide a graphical representation of theamount of time remaining in the incubation period for each occupied well(810). In addition to the foregoing, indicator analyzer (800) may beconfigured and operable in accordance with at least some of theteachings of U.S. Provisional Patent App. No. 62/316,722, the disclosureof which is incorporated by reference herein.

V. EXEMPLARY VARIABLE RESISTANCE BIOLOGICAL INDICATOR

As noted above, a biological indicator (700) may have openings in cap(720), housing (710), or elsewhere that will allow gasses (e.g., air orsterilant, etc.) to pass into housing (710) and expose themicroorganisms contained therein to sterilant. The size and/orconfiguration of such an opening can be chosen during manufacture toallow for a desired level of resistance to gasses or other substancesentering biological indicator (700), with smaller openings providing alower volume of flow and resulting in a higher resistance, and largeropenings providing a higher volume of flow and resulting in a lowerresistance. Different sterilization cycles that may use a biologicalindicator (700) may operate at varying levels of pressurization, varyingdurations, and may use varying types of sterilant in order to achieveproper sterilization of the numbers and types of medical devices beingsterilized.

Due to the variety of factors that must be accounted for in theinteractions between a particular sterilization cycle and a biologicalindicator (700), in some instances a biological indicator (700) with aparticular vent size or configuration chosen at the time of manufacturemay not be ideal for the sterilization cycle it is used with. Forexample, certain sterilization cycles may operate at a high pressure inorder to ensure sterilization of instruments that have movable joints,long and narrow lumens, or other features that might be difficult toreach with sterilant. However, a biological indicator (700) with aparticular vent size or configuration and corresponding resistancechosen at the time of manufacture may not offer a level of resistancethat ideally simulates the hard to reach areas of the above instrument.In order to address the circumstances where a standard static resistancebiological indicator (700) may not be ideally suited for the chosensterilization cycle, a variable resistance biological indicator (1200)and variable resistance biological indicator cap (1230) are describedherein, which can support multiple openings sizes or configurations, andthereby selectively provide multiple corresponding resistances, suchthat a level of resistance may be selected at the time of use ratherthan at the time of manufacture.

A. Exemplary Variable Resistance Biological Indicator with Body Display

FIGS. 7A and 7B show an exemplary biological indicator (1200) with abody displayed resistance indicator (1212). Except as otherwisedescribed below, biological indicator (1200) of this example may havethe same components and functionality as biological indicator (700)described above. For instance, biological indicator (1200) of thisexample has a housing (1206), a cap (1202), openings in cap (1202) toallow sterilant to enter, and other internal components not pictured inFIGS. 7A-7B.

The variable biological indicator (1200) of this example also includesan inner housing (1210) that is able to rotate separately from the outerhousing (1206). Portions of inner housing (1210) are visible through anindicator viewer or window (1208) in outer housing (1206). The variableresistance biological indicator (1200) additionally has a rotatable cap(1202) that is configured to rotate relative to outer housing (1206)when a rotational force (1204) is applied. Rotatable cap (1202) issecured to inner housing (1210) such that rotation of the rotatable cap(1202) relative to outer housing (1206) will cause the inner housing(1210) to rotate relative to outer housing (1206). In effect, thisallows differing portions of inner housing (1210) to be displayedthrough the window (1208) as rotatable cap (1202) is rotated, causingthe inner housing (1210) to rotate inside the outer housing (1206).

In the present example, rotation of the rotatable cap (1202) and theinner housing (1210) also causes openings or vents (not pictured) in thecap (1202) to change in effective size, thereby providing variableventing configurations. By providing variable venting configurations,biological indicator (1200) will vary the resistance provided to thesterilant of sterilizing cabinet (150) reaching the microorganismscontained within biological indicator (1200). In other words, with cap(1202) providing a first venting configuration, the sterilant ofsterilizing cabinet (150) may encounter a first degree of resistance inreaching the microorganisms contained within biological indicator(1200). With cap (1202) providing a second venting configuration, thesterilant of sterilizing cabinet (150) may encounter a second degree ofresistance in reaching the microorganisms contained within biologicalindicator (1200). It should be understood that cap (1202) may beoperable to selectively provide any suitable number of different ventingconfigurations.

By way of example only, different venting configurations may be providedby having vents of different sizes placed around the circumference ofcap (1202) and housing (1206), so that when cap (1202) is at a firstrotational position relative to housing (1206), a small vent in cap(1202) lines up with a small vent in housing (1206) while other ventsare blocked, limiting the effective size of the vents to the size of theopened small vent. As cap (1202) is rotated to a second positionrelative to outer housing (1206), a medium sized vent or, for example,two small vents, line up with a similar size and number of vents inhousing (1206), while other vents are blocked, limiting the effectivesize of the vents to the medium vent or the two small vents. In thismanner, as the cap (1202) is rotated relative to the outer housing(1206), the effective size of vents can be adjusted, allowing sterilantto encounter varying levels of resistance in order to enter the housing(1210).

In addition to allowing a rotational force (1204) to rotate the cap(1202) to one or more positions to allow a variable level of resistance,rotation of the cap (1202) may also simultaneously expose one or moreresistance indicators (1212). While some portions of the inner housing(1210) may be blank or may by color, text, or other visual identifierindicate a neutral state, other portions of inner housing (1210) mayhave one or more resistance indicators (1212) that may be exposedthrough the window (1208) of the outer housing (1206) as cap (1202) isrotated. It should be understood that, since rotation of cap (1202)relative to outer housing (1206) will simultaneously change the ventingconfiguration and the exposure of a particular resistance indicator(1212) through window (1208), the particular resistance indicator (1212)that is exposed through window (1208) will be indicative of theparticular venting configuration provided by cap (1202).

Each resistance indicator (1212) may comprise one or more human readableindicators, machine readable indicators, or both. Human readableindicators may include, for example, numbers, letters, text, symbols,colors, patterns, or other indicators which may be readily perceived bya user. Machine readable indicators may include, for example, any humanreadable indicator that may be readily captured and interpreted by amachine, imaging device, or computer, as well as barcodes, data matrixcodes, QR codes, other visually encoded data, data containing RFIDchips, data containing NFC chips, other wirelessly transmitted data, orsimilar technologies. In the case of passive tags such as RFID chips,NFC chips, or other indicators that may transmit data wirelessly, outerhousing (1206) may additionally contain an electromagnetic shieldingsuch as a layer of aluminum or another appropriate material that mayprevent a wireless scanning device from detecting machine readableindicators that are covered by the outer housing (1206), while allowinga single machine readable indicator (1212) that is exposed through thewindow (1208) to be successfully read by the scanning device.

In an example such as that shown in FIG. 7B, a human readable portion ofa resistance indicator (1212) may assist a user in rotating the cap(1202) to an appropriate position given such factors as thesterilization cycle type that the biological indicator is being used in,the type of sterilizing cabinet (150) being used, or other factors. Themachine readable portion of the resistance indicator (1212) may allow animaging device, such as a barcode scanner, or a wireless device, such asan RFID reader, to capture data from the machine readable portion andverify it against other records to, for example, ensure that anappropriate level of resistance has been configured by the user for thatsterilization cycle type or sterilizing cabinet (150) type.

The number of different vent configurations and corresponding indicators(1212) may vary by implementation, and it should be understood that cap(1202) and outer housing (1206) may be configured to provide anysuitable number of vent configurations to choose from. Likewise, thesize of the window (1208) and the indicator (1212) may be varied greatlyto suit almost any needed number of resistance indicators (1212). Forexample, in versions where a sterilizing cabinet (150) may support fourdifferent types of sterilizing cycles, each having their own optimallevel of biological indicator resistance, cap (1202) and outer housing(1206) may be operable to provide five different venting configurations.These different venting configurations could include a sealed ornon-vented configuration for use when biological indicator (1200) is instorage; a first vented configuration corresponding to a firststerilization cycle; a second vented configuration corresponding to asecond sterilization cycle; and so on. Each of the first, second, third,and fourth vented configurations could result in an effective vent sizeappropriate for the corresponding sterilization cycle; and also causethe window (1208) to display a human readable indicator (1212)identifying the corresponding sterilization cycle type, a machinereadable indicator (1212) identifying the corresponding sterilizationcycle type, or both.

Some machine readable resistance indicators (1212), such as RFID and NFCchips, may also allow a scanning device to write data to the RFID or NFCchip that may then remain associated with that biological indicator(1200), providing an additional useful way to associate data with abiological indicator (1200) on an ad hoc basis. These additionalcapabilities allow a system to be implemented to automatically verifyuser configurations of biological indicators (1200) in order to reducehuman error; and also create additional sources of data that may be usedto, for example, allow offline operation of the system or providefurther automated safeguards against human error. Such implementationsinclude those discussed in further detail below and others that will beapparent to one of ordinary skill in the art in light of the disclosureherein.

While the variable resistance biological indicator (1200) of FIGS. 7A-7Bhas been described as using a rotational movement of a cap (1202) orhousing (1206) to allow adjustment to one or more different ventingconfigurations while also revealing corresponding human and/or machinereadable indicators (1212), it should be understood that other types ofadjustment are possible as will be apparent to one of ordinary skill inthe art in light of the disclosure herein. For example, a slidingportion of housing (1206) could be moved linearly along a track or slotin order to expose or reveal vents and indicators, a removable pull tabcould be removed in order to expose or reveal vents and indicators, orother features may be used to provide variable venting configurations.

B. Exemplary Variable Resistance Biological Indicator with Cap Display

FIGS. 8A-8C show an exemplary variable resistance biological indicatorcap (1230) with a cap displayed resistance indicator (1218, 1222, 1226).The variable resistance biological indicator cap (1230) of FIGS. 8A-8Cmay be used with a variety of biological indicators such as thebiological indicator (700) of FIG. 4, the biological indicator (1200) ofFIGS. 7A-7B, or other biological indicators. The variable resistancebiological indicator cap (1230) of FIGS. 8A-8C may also have variableopenings or vents (1232, 1234, 1236, 1238) to allow sterilant to reachthe microorganisms contained within biological indicator (700, 1200)with a selected degree of resistance during a sterilization cycle.

As shown in FIG. 8A, the variable resistance biological indicator cap(1230) of the present example has a machine readable indicator window(1214), a human readable indicator window (1216), and a primary vent(1232) passing through an outer surface of the variable resistancebiological indicator cap (1230). The variable resistance biologicalindicator cap (1230) of the present example also has an inner surface(not pictured) with human readable indicators (1220, 1224, 1228) printedor affixed to the inner surface, machine readable indicators (1218,1222, 1226) printed or affixed to the inner surface, and varying sizesof control vents (1234, 1236, 1238) passing through the inner surface.The inner surface may be a disc or other shape sized to fit within thevariable resistance biological indicator cap (1230). The inner surfacemay be fixed or connected to the housing (710, 1206) of a biologicalindicator (700, 1200) such that the inner surface is rotationally fixedrelative to the housing (710, 1206). The outer surface of the variableresistance biological indicator cap (1230) is movably coupled with theinner surface on a track, rail, or other mount such that it may rotateindependently of the inner surface when a rotational force (1204) isapplied to the variable resistance biological indicator cap (1230),thereby causing the outer surface to rotate relative to the housing(710, 1206) while the inner surface remains stationary relative to thehousing (710, 1206).

As the outer surface of the variable resistance biological indicator cap(1230) rotates relative to the stationary inner surface, the indicatorwindows (1214, 1216) will rotate over top of the stationary innersurface and expose one or more human readable indicators (1220, 1224,1228), machine readable indicators (1218, 1222, 1226), or both dependingupon the position that the outer surface of the variable resistancebiological indicator cap (1230) is rotated to. Simultaneously, as thevariable resistance biological indicator cap (1230) rotates, the primaryvent (1232) will be positioned over top of a particular control vent(1234, 1236, 1238). Thus, the variable resistance biological indicatorcap (1230) will simultaneously change the venting configuration to aneffective vent size matching the size of a control vent (1234, 1236,1238), change the exposure of a corresponding human readable indicator(1220, 1224, 1228), and change the exposure of a corresponding machinereadable indicators (1218, 1222, 1226) when the variable resistancebiological indicator cap (1230) is rotated relative to the outer housing(710, 1206) of biological indicator (700, 1200).

FIG. 8A shows the variable resistance biological indicator cap (1230)rotated to a first position that exposes a first human readableindicator (1220) and a first machine readable indicator (1218), whileprimary vent (1232) is positioned over top of a first control vent(1234), resulting in an effective vent size matching the first controlvent (1234). FIG. 8B shows the variable resistance biological indicatorcap (1230) rotated to a second position that exposes a second set ofindicators (1222, 1224), while primary vent (1232) is positioned overtop of a second control vent (1236), resulting in an effective vent sizematching the second control vent (1236). As shown, second control vent(1236) is larger than first control vent (1234), such that first controlvent (1234) provides greater resistance to sterilant than second controlvent (1236). FIG. 8C shows the variable resistance biological indicatorcap (1230) rotated to a third position that exposes a third set ofindicators (1226, 1228), while primary vent (1232) is positioned overtop of a third control vent (1238), resulting in an effective vent sizematching the third control vent (1238). As shown, third control vent(1238) is larger than second control vent (1236), such that secondcontrol vent (1236) provides greater resistance to sterilant than thirdcontrol vent (1238). While FIG. 8A-8C show one possible arrangement ofthe control vents (1234, 1236, 1238), human readable indicators (1220,1224, 1228), and machine readable indicators (1218, 1222, 1226), otherarrangements will be apparent to those of ordinary skill in the art inlight of the disclosure herein.

As with the body display indicator of FIGS. 7A and 7B, the humanreadable portion of a resistance indicator (1220, 1224, 1228) may assista user in rotating the variable resistance biological indicator cap(1230) to an appropriate position to achieve a desired ventingconfiguration, given such factors as the sterilization cycle type thatthe biological indicator (700, 1200) is being used in, the type ofsterilizing cabinet (150) being used, or other factors. The machinereadable portion of the resistance indicator (1218, 1222, 1226) mayallow an imaging device, such as identification tag reader (166), or awireless device, such as an RFID reader, to capture data from themachine readable portion and verify it against other records to, forexample, ensure that an appropriate level of resistance has beenconfigured by the user for that sterilization cycle type or cabinet(150) type.

In versions where the machine readable portion comprises an RFIDfeature, an NFC feature, or similar feature, variable resistancebiological indicator cap (1230) may also have a layer of electromagneticshielding material between the outer surface and the inner surface inorder to prevent an RFID or NFC scanning device from reading informationfrom machine readable indicators (1218, 1222, 1226) that are not exposedthrough the machine readable indicator window based upon the currentposition of the variable resistance biological indicator cap (1230). Thenumber of positions supported by the variable resistance biologicalindicator cap (1230) may vary, but it should be understood that the sizeand arrangement of indicators (1218, 1220, 1222, 1224, 1226, 1228),indicator windows (1214, 1216), and vents (1232, 1234, 1236, 1238) canbe varied to support almost any needed number of positions correspondingto venting configurations.

It should also be noted that, while FIGS. 8A-8C show a variableresistance biological indicator cap (1230) that is adjusted by rotationof an outer surface of the variable resistance biological indicator cap(1230) relative to an inner surface, a similar adjustment could also beachieved with an outer surface portion that slides in one or moredirections along a track, rail, or other mount relative to an innersurface rather than rotating, with different positions along the trackcorresponding to different venting configurations as described above, orwith removable pull tabs that can be removed from the outer surface toreveal one or more corresponding indicators (1218, 1220, 1222, 1224,1226, 1228) and control vents (1234, 1236, 1238).

As with the biological indicator (1200) of FIGS. 7A and 7B, some machinereadable resistance indicators (1212), such as RFID and NFC chips, mayalso allow a scanning device to write data to the RFID or NFC chip thatmay then remain associated with that biological indicator (700, 1200),providing an additional useful way to associate data with a biologicalindicator (700, 1200) on an ad hoc basis. These additional capabilitiesallow a system to be implemented to automatically verify userconfigurations of biological indicators (700, 1200) in order to reducehuman error, and also create additional sources of data that may be usedto, for example, allow offline operation of the system or providefurther automated safeguards against human error. Such implementationsinclude those discussed in further detail below and others that will beapparent to one of ordinary skill in the art in light of the disclosureherein.

VI. EXEMPLARY METHODS OF USING VARIABLE RESISTANCE BIOLOGICAL INDICATORS

The variable resistance biological indicators (700, 1200) disclosedabove offer several advantages in addition to the ability to adjustresistance of exposure of microorganisms to sterilant from sterilizingcabinet (150). For example, since machine readable indicators (1212,1218, 1222, 1226) can be exposed or hidden as part of the sameadjustment that changes resistance for a biological indicator (700,1200) (e.g. a cap (1202) or variable resistance biological indicator cap(1230) rotation that adjusts vent size while also exposing an indicator(1212, 1218, 1222, 1226) on the housing (1206) or the variableresistance biological indicator cap (1230)) the current configuration ofany given biological indicator (700, 1200) can be automaticallydetermined based upon the machine readable indicator (1212, 1218, 1222,1226) that is currently exposed at any point of contact that thebiological indicator (700, 1200) has with a device having an appropriatescanner. This could include a sterilizing cabinet (150) visuallyscanning a visual indicator or electromagnetically scanning an RFID orNFC indicator via a visual scanner or RFID transceiver placed near orwithin the sterilizing cabinet (150), or, for example, viaidentification tag reader (166) having such capabilities. This couldalso include using a similar scanner or identification tag reader (870)at an indicator analyzer (800), a handheld scanner, mobile phone, orother mobile device that could be used for identifying biologicalindicators as they change hands or are disposed of after use, or otherdevices that may come into contact with a variable resistance biologicalindicator (1200).

Each point of contact where a biological indicator (700, 1200) isscanned provides an opportunity to read information from a machinereadable indicator (1212, 1218, 1222, 1226), which could include acurrent variable resistance vent configuration, but could also include aunique identifier for that biological indicator (700, 1200). In suchversions, a biological indicator (700, 1200) could generate a trail ofunique identifications as it moved from receipt, to storage, to use in asterilization cycle, to incubation and analysis, then to disposal, witheach unique identification point being stored in a record server. Withsuch a data set available, any biological indicator (700, 1200) can berelated back to the sterilization cycles and procedures it was used in,and any sterilization cycle or procedure may be related back to abiological indicator (700, 1200) that it is associated with. Thisprovides numerous opportunities to both identify and reduce human errorsuch as when a biological indicator (700, 1200) is used in asterilization cycle and then misplaced or misidentified due to humanerror, when a biological indicator (700, 1200) is used in asterilization cycle and then mistakenly left in the sterilizing cabinet(150), or other scenarios in which a detailed history available from therecord server may aid to reconstruct events. Additionally, in versionshaving machine readable indicators that include some form of memory,such as an RFID or NFC indicator, there is an additional capability towrite some or all of the audit trail data to the biological indicator(700, 1200) itself. This could allow for continued retention of data,transmission of data between devices, and reconstruction of past eventseven when network communications are interrupted or the record server isunavailable for any reason, or when a sterilizing cabinet (150) is notdirectly networked with an indicator analyzer (800), for example.

The following discussion provides various examples of how biologicalindicators (700, 1200) with variable resistance features may be used ina system formed by a sterilizing cabinet (150), a biological indicatoranalyzer (800), and other components. Other suitable ways in whichbiological indicators (700, 1200) with variable resistance vent featuresmay be used in such systems will be apparent to those of ordinary skillin the art in view of the teachings herein.

A. Exemplary Basic Steps for Using Variable Resistance Indicator

As disclosed above, a variable resistance biological indicator (700,1200) may provide a number of features or advantages beyond the abilityto adjust the resistance of a cap vent or other opening to control theflow of sterilant into the biological indicator (700, 1200). Whiletaking advantages of different features may require particular systemcomponents, network configurations, or methods of use, some basic stepsmay be shared by many implementations and methods. For example, whileFIGS. 7-11 show different exemplary methods of using a variableresistance biological indicator (700, 1200) with some or all of thefeatures described above, each of the shown exemplary methods has acommon set of initial steps. However, while these common steps areshared by FIGS. 7-11, it should not be assumed that any method of usinga variable resistance biological indicator (700, 1200) must begin withthese steps.

FIG. 9 shows a set of steps that may be performed with a variableresistance biological indicator (700, 1200), sterilizing cabinet (150),and indicator analyzer (800) in order to determine the efficacy of asterilization cycle while reducing the potential for human errorassociated with the use of the variable resistance biological indicator(700, 1200). Initially, a user may select (block 920) or make anindication that they would like to perform a sterilizing cycle with abiological indicator (700, 1200) via touch screen display (160) (or someother interface) of the sterilizing cabinet (150). A user may alsoselect (block 922) the vent configuration to provide a desired level ofvariable resistance for a variable resistance biological indicator (700,1200) by rotating the cap (1202), variable resistance biologicalindicator cap (1230), or body (1206) so that the opening or window(1208, 1214, 1216) shows a human readable indicator (1212, 1220, 1224,1228) and/or machine readable indicator (1212, 1218, 1222, 1226) thatcorrespond to the appropriate sterilizing cycle that has been or will beselected via the sterilizing cabinet (150). It should be understood thattouch screen display (160) (or some other interface) of the sterilizingcabinet (150) may prompt the user what vent configuration to selectbased on the user's sterilization cycle selection, based on loadcharacteristics (e.g., materials, geometries, quantities, temperature,etc.), and/or based on other factors.

As described above in relation to the variable resistance biologicalindicator with body display (1200) and variable resistance biologicalindicator cap (1230) with cap display, rotating or otherwise positioningthe cap (1202) or the variable resistance biological indicator cap(1230) at a position where one or more indicators (1212, 1218, 1220,1222, 1224, 1226, 1228) are shown, based on the selection step (block922), also places the variable resistance biological indicator (1200) orvariable resistance biological indicator cap (1230) in a ventingconfiguration that corresponds to the shown indicators (i.e. by aligninga primary vent (1232) over top of a control vent (1234, 1236, 1238) or asimilar implementation). The user may also scan or otherwise read (block924) one or more machine readable indicators (1212, 1218, 1222, 1226)from the variable resistance biological indicator (700, 1200) usingidentification tag reader (166), some other barcode scanner, an RFIDscanner, or some other appropriate scanner.

Information retrieved by scanning (block 924) may include, for example,an indication of the current level of variable resistance provided bythe selected vent configuration, the sterilization cycle that theselected level of variable resistance is associated with, a biologicalindicator (700, 1200) identifier, a biological indicator (700, 1200)batch identifier, a biological indicator (700, 1200) manufactureridentifier, a biological indicator (700, 1200) expiration date, and/orother information that may readily be encoded within a barcode or otherimage, or an RFID chip or other short range wireless device. Suchinformation may be used to determine if the biological indicator (700,1200) selected by the user is valid (block 926), or whether, forexample, an unsupported vent configuration has been chosen, thebiological indicator (700, 1200) has expired, the biological indicator(700, 1200) is not supported for that sterilizing cabinet (150) orselected sterilization cycle, the biological indicator (700, 1200) hasalready been used in a different sterilization cycle, that batch ofbiological indicators (700, 1200) has been flagged or recalled by themanufacturer, or other similar reasons for invalidity. If anyinformation provided by the scan (block 924) indicates that thebiological indicator is erroneously configured (i.e. by having beenrotated to an improper position) or otherwise unusable, the sterilizingcabinet (150) may alert (block 928) the user of one or more problemsthat may need to be addressed before the sterilization cycle begins.

If it is determined that the biological indicator (700, 1200) is validlyconfigured and usable (block 926), the sterilizing cabinet (150) mayunlock or open the sterilizing chamber (152), if it is locked, orotherwise allow a user to load (block 930) the medical devices or otherinstruments that are to be sterilized in sterilizing chamber (152); andplace (block 934) the selected biological indicator (700, 1200) insterilizing chamber (152). The sterilizing cabinet (150) may also promptor allow the user to select or confirm (block 936) the sterilizationcycle that is to be performed. The sterilizing cabinet (150) may thenconfirm that the selected (block 936) sterilization cycle matches thesterilization cycle that the variable resistance biological indicator(700, 1200) was configured for (block 922) based upon the data scanned(block 924) from the variable resistance biological indicator (700,1200). If it is determined that the sterilization cycle selected (block936) via the sterilizing cabinet (150) does not match the sterilizationcycle or variable resistance that the biological indicator (700, 1200)was configured for (block 922), the user may be alerted (block 940)indicating the mismatch and given a chance to select (block 932) a newcycle via the sterilizing cabinet (150) or select (block 932) a new ventconfiguration for the biological indicator (700, 1200) by removing itfrom the sterilizing cabinet (150) and rotating the cap (1202), variableresistance biological indicator cap (1230), or housing (1206).

Many of the of the initial steps discussed above may, in some versions,be enforced by automated means, such as locking the sterilizing cabinet(150) sterilizing chamber (152) until the biological indicator (700,1200) is scanned (block 924), unlocking and opening the door tosterilizing chamber (152) when a cycle mismatch is detected (block 938),creating audible alerts when an error is detected (block 928, block940), using a scanner within the sterilizing chamber (152) to re-scanthe biological indicator (700, 1200) after it has been placed and afterthe sterilizing chamber (152) has been sealed to ensure that biologicalindicator (700, 1200) has not been reconfigured since the first scan(block 924), or other safeguards. Many of the initial steps may also beshown or explained to a user of the sterilizing cabinet (150) via atouch screen display (160) or other display, and may include, forexample, pictures and text showing or explaining proper variableresistance biological indicator (700, 1200) rotation and configuration,scanning, load placement, biological indicator (700, 1200) placement,and other helpful information.

After one or more of these exemplary initial steps are performed, a setof variable steps may be performed to complete the process, with thevariable steps being determined based upon such factors as networkcapabilities, system components and capabilities, or other factors, asdescribed below or as will be apparent to those of ordinary skill in theart in light of the disclosure herein.

B. Exemplary Cycle Completion with Scanner and Network with SterilizingCabinet as Master Device

The remaining exemplary steps of FIG. 9, beginning after a successfuldetermination (block 938) that a sterilization cycle selected via thesterilizing cabinet (150) matches a vent configuration selected on thevariable resistance biological indicator (700, 1200), may be appropriatefor a system that uses a visual scanner or wireless scanner for scanning(block 924) identifiers of biological indicators (700, 1200) and whichhas a stable network that will allow network communication between thesterilizing cabinet (150) and the indicator analyzer (800). Theexemplary steps of FIG. 9 may also show a preference for treating thesterilizing cabinet (150) as the master device, which may be appropriatewhere the sterilizing cabinet (150) has a dedicated user or clinician,or where an indicator analyzer (800) has limited ability to outputinformation or interact with a user.

The sterilizing cabinet (150), having been unable to identify anyerroneous configurations or other problems, may start the sterilizationcycle (block 942), which may include load conditioning, injection ofsterilization, pressure adjustments, and other actions as discussedabove with reference to FIGS. 2-3. The sterilizing cabinet (150) mayalso alert (block 944) the indicator analyzer (800) via the network thata sterilization cycle is currently being performed using a biologicalindicator (700, 1200), so that information is available via theindicator analyzer (800) identifying the sterilization cycle type,sterilizing cabinet (150), biological indicator (700, 1200) identifier,time, date, and other information relating to the sterilizing cycle thatmay be pertinent to the biological indicator (700, 1200) analysis. Suchinformation could be used to assist a user of the indicator analyzer(800) in prioritizing use of the indicator analyzer (800) or other tasksthat may need to be completed before the new biological indicator (700,1200) arrives for analysis.

When the sterilization cycle completes, the sterilizing cabinet (150)may remind (block 946) a user via a display (160) or other userinterface that the used biological indicator (700, 1200) should beremoved from the sterilizing cabinet (150) and transferred to theindicator analyzer (800) so that it can be analyzed within a suitabletime frame. This reminder could be enforced by, for example, a scannerwithin the sterilizing cabinet (152) detecting the presence of thebiological indicator (700, 1200) within sterilizing chamber (152) andcausing the sterilizing cabinet (150) to emit a persistent alert noiseuntil the biological indicator (700, 1200) is removed. Once scanned(block 948) at an indicator analyzer (800), by way of identification tagreader (870) or a handheld scanner, before biological indicator (700,1200) is placed in a well (810), or by another scanner that is able toautomatically scan a variable resistance biological indicator (1200) orvariable resistance biological indicator cap (1230) after a biologicalindicator (700, 1200) is placed in a well (810), the indicator analyzer(800) may take such steps as verifying that the biological indicator(700, 1200) matches a biological indicator (700, 1200) that it wasearlier notified of (block 944), that the biological indicator (700,1200) has been placed in or will be placed in the analyzer (800) withina suitable time frame, or that no other inconsistencies in the auditabletrail of the biological indicator (700, 1200) exist (e.g. duplicatesterilization cycles).

The indicator analyzer (800) may also acknowledge (block 950) receipt ofthe biological indicator (700, 1200) by providing data via the networkto the sterilizing cabinet (150) indicating that the biologicalindicator (700, 1200) was placed in the indicator analyzer (800). Thesterilizing cabinet (150) could use this information to, for example,display a confirmation of proper handling of the biological indicator(700, 1200) via display (160), or prevent further alerts or alarms thatmight otherwise originate from the sterilizing cabinet (150) and beassociated with the biological indicator (700, 1200), such as an alarmthat might sound if a biological indicator (700, 1200) is not placed inan indicator analyzer (800) within one hour (or some other duration)after the biological indicator (700, 1200) is used in a sterilizationcycle.

The indicator analyzer (800) may also analyze (block 952) the biologicalindicator (700, 1200) in order to determine whether the sterilizationcycle was successful or not. Once the analysis (block 952) is complete,the indicator analyzer (800) may provide analysis results (block 954)via display (850) of the indicator analyzer (800), a networktransmission of data to be displayed via display (160) of thesterilizing cabinet (150), and/or a network transmission to anotherdevice such as a smartphone, tablet, or other personal device. Suchinformation could be used to maintain and create records of thecompleted sterilization cycle and biological indicator (700, 1200) used,to provide records to another device such as a records server, or todisable or prevent further notifications or alerts relating to thecompleted sterilization cycle or biological indicator (700, 1200). Theseresults may also be automatically printed (block 956) via thesterilizing cabinet (150) printer (170) so that hard copies may bemaintained or used for further analysis. Of course, this printing step(block 956) is merely optional and may be omitted.

C. Exemplary Cycle Completion with Scanner and Network with IndicatorAnalyzer as Master Device

FIG. 10 shows a process that begins with the same set of steps (blocks920, 922, 924, 926, 928, 930, 932, 934, 936, 938, 940) as the process ofFIG. 9. Thus, discussion of those steps will not be repeated here. Theremaining exemplary steps of FIG. 10, beginning after a successfuldetermination (block 938) that a sterilization cycle selected via thesterilizing cabinet (150) matches a vent configuration selected on thevariable resistance biological indicator (700, 1200), may be appropriatefor a system that uses a visual scanner or wireless scanner for scanning(block 924) a variable resistance biological indicator (1200) orvariable resistance biological indicator cap (1230), and which has astable network that will allow network communication between thesterilizing cabinet (150) and the indicator analyzer (800). Theexemplary steps of FIG. 10 may also show a preference for treating theindicator analyzer (800) as the master device, which may be appropriatewhere the indicator analyzer (800) has a dedicated user or clinician, orwhere the sterilizing cabinet (150) has limited ability to outputinformation or interact with a user.

As with FIG. 9, when no errors are identified, the sterilization cyclemay begin (block 942) and the indicator analyzer (800) may receive(block 944) information indicating that a particular biologicalindicator (700, 1200) is being used in a sterilization cycle, as hasbeen described above. The sterilizing cabinet (150) may also provideinformation to the indicator analyzer (800) that provides (block 958)detailed information regarding the sterilization cycle, which couldinclude cycle completion time, cycle pressure, cycle, temperature, loadconditioning results, or other detailed information that may be used bythe indicator analyzer (800) during its analysis or to maintain anauditable trail of the biological indicator (700, 1200) during thesterilization cycle.

Once the sterilization cycle is complete, the biological indicator (700,1200) may be removed from the sterilizing cabinet (150) and scanned(block 948) and placed in a well (810) of the indicator analyzer (800)so that it can be analyzed (block 952), as has been described above.When analysis (block 952) is complete, the indicator analyzer (800) mayprovide information on the results of the analysis to a user or recordsserver, and print (block 960) a hard copy of the results that may beused to maintain records or for further analysis. As noted above, thisprinting step (block 960) is merely optional and may be omitted ifdesired.

D. Exemplary Cycle Completion with Scanner and Network with RecordServer as Master

FIG. 11 shows a process that begins with the same set of steps (blocks920, 922, 924, 926, 928, 930, 932, 934, 936, 938, 940) as the process ofFIG. 9. Thus, discussion of those steps will not be repeated here. Theremaining exemplary steps of FIG. 11, beginning after a successfuldetermination (block 938) that a sterilization cycle selected via thesterilizing cabinet (150) matches a vent configuration selected on thevariable resistance biological indicator (700, 1200), may be appropriatefor a system that uses a visual scanner or wireless scanner for scanning(block 924) a variable resistance biological indicator (1230) orvariable resistance biological indicator cap (1230), and which has astable network that will allow network communication between thesterilizing cabinet (150), the indicator analyzer (800), and a recordserver. The exemplary steps of FIG. 11 may also show a preference fortreating an external record server (not shown) as the master device,which may be appropriate where the record server serves a role ofmonitoring sterilization cycles and biological indicator use, or wherethe sterilizing cabinet (150) and/or indicator analyzer (800) havelimited ability to output information or interact with a user.

As with FIG. 9, when no errors are identified the sterilization cyclemay begin (block 942) and the indicator analyzer (800) may receive(block 944) information indicating that a particular biologicalindicator (700, 1200) is being used in a sterilization cycle, as hasbeen described above. In the exemplary steps shown, the sterilizingcabinet (150) may send (block 962) detailed information on thesterilization cycle to the record server, which may include informationsuch as sterilization cycle identifier, sterilizing cabinet identifier(150), user identifier, start time, end time, biological indicator (700,1200) identifier, lot number, cycle details such as pressure,temperature, load type, or other information generated and associatedwith a sterilization cycle that may be pertinent to monitoring theperformance of sterilization cycles or maintaining an auditable trail ofinformation for cycles and biological indicators (700, 1200).

When the sterilization cycle completes, a user may remove the biologicalindicator (700, 1200) from the sterilizing cabinet (150) so that thebiological indicator (700, 1200) can be scanned (block 948) and placedin a well (810) of the indicator analyzer (800) and the results of thesterilization cycle can be analyzed (block 952), as has been describedabove. The indicator analyzer (800) may send (block 964) resultsinformation to the record server, which may be used by a user of therecords server to monitor the results of one or more sterilizationcycles or biological indicator (700, 1200) analyses; or may be used tomaintain records relating to the performance of cycles and analysis ofbiological indicators (700, 1200). The record server may print (block966) some or all of the information provided so that it can bemaintained in hard copy or used for further analysis. As noted above,this printing step (block 966) is merely optional and may be omitted ifdesired.

E. Exemplary Cycle Completion with Scanner, Writer, and IndicatorAnalyzer as Master

FIG. 12 shows a process that begins with the same set of steps (blocks920, 922, 924, 926, 928, 930, 932, 934, 936, 938, 940) as the process ofFIG. 9. Thus, discussion of those steps will not be repeated here. Theremaining exemplary steps of FIG. 12, beginning after a successfuldetermination (block 938) that a sterilization cycle selected via thesterilizing cabinet (150) matches a vent configuration selected on thevariable resistance biological indicator (700, 1200), may be appropriatefor a system that uses a wireless scanner that is capable of scanning(block 924) information from and writing data to a wireless memory suchas an RFID or NFC chip of a variable resistance biological indicator(1200) or variable resistance biological indicator cap (1230), with orwithout a network providing communications between the sterilizingcabinet (150) and the indicator analyzer (800). The exemplary steps ofFIG. 12 may also show a preference for treating the indicator analyzer(800) as the master device, which may be appropriate where there is nonetwork connectivity between the indicator analyzer (800) and thesterilizing cabinet (150) that will readily allow the indicator analyzer(800) to notify the sterilizing cabinet (800) of the results of ananalysis.

As with FIG. 9, when no errors are identified the sterilization cyclemay begin (block 942). Since the exemplary steps of FIG. 12 do not relyon network connectivity between the sterilizing cabinet (150) and theindicator analyzer (800), there may not be a direct exchange of cycleinformation between the devices. Instead, a user with a handheldscanner, or the sterilizing cabinet (150) using a short range scanner(e.g., identification tag reader (166)), may scan (block 968) a machinereadable indicator of the biological indicator (700, 1200) and writesterilization cycle information to the machine readable indicator (1212,1218, 1222, 1226) where it may be stored (block 970).

After the sterilization cycle is complete, a user may remove thebiological indicator (700, 1200) from sterilizing cabinet (150) andtransport biological indicator (700, 1200) to the indicator analyzer(800) where biological indicator (700, 1200) may be scanned (block 948).In addition to information that may have been present on a machinereadable indicator (1212, 1218, 1222, 1226) of the biological indicator(700, 1200) prior to use of biological indicator (700, 1200) insterilizing cabinet (150), such as a biological indicator (700, 1200)identifier, expiration date, or other similar information, the machinereadable indicator (1212, 1218, 1222, 1226) may also now containsterilization cycle related information that was stored (block 970)there by the sterilizing chamber (150). In effect, this allows forupdated information to be transported directly on biological indicator(700, 1200), between the sterilizing cabinet (150) and the indicatoranalyzer (800), during physical transportation of the biologicalindicator (700, 1200) to the well (810), rather than by reliance onnetwork communications. The indicator analyzer (800) may also performanalyses (block 952) of the biological indicator (700, 1200) and print(block 960) the results, as has been described above.

F. Exemplary Cycle Completion with Automated Variable ResistanceConfiguration

FIG. 13 shows a process that begins with several of the same steps(blocks 920, 924, 926, 928, 930, 934, 936) as the process of FIG. 9.Thus, discussion of those steps will not be repeated here. It should benoted that the process of FIG. 13 in particular does not require a userto select (block 922) a vent configuration before placing (block 934)the biological indicator (700, 1200) in the sterilizing cabinet (150)and selecting (block 936) the sterilization cycle. The process of FIG.13 may be appropriate for a system having a sterilizing cabinet (150)that is capable of automatically rotating a cap (1202, 1230) or housing(710, 1206) of a variable resistance biological indicator through theuse of a rotatable or otherwise movable gripping device and biologicalindicator holder incorporated with the sterilizing cabinet (150). Withsuch a sterilizing cabinet, if a mismatch was identified, thesterilizing cabinet (150) could deploy a rotatable gripping or movingdevice to grip the cap (1202, 1230) or housing (710, 1206) of thebiological indicator while a biological indicator holder within thesterilizing cabinet immobilizes the non-rotating portion of thebiological indicator (700, 1200). Once gripped, the cap (1202, 1230) orhousing (710, 1206) could be automatically rotated, adjusted, orotherwise manipulated (block 972) until the sterilizing cabinet (150) isable to locate a machine readable indicator (1212, 1218, 1222, 1226) onthe variable resistance biological indicator cap (1230) or variableresistance biological indicator (1200) that matches the selected cycle.Such an implementation may be useful in preventing time consumingadjustments of biological indicators (700, 1200) after a sterilizingcabinet (150) has already been sealed and prepared for a sterilizationcycle, and may also reduce human error in configuring variableresistance biological indicators (700, 1200).

Once the variable resistance biological indicator (1200) or variableresistance biological indicator cap (1230) is adjusted to theappropriate position and vent configuration, the sterilization cycle maybegin (block 942), with information being sent (block 944) to theindicator analyzer (800) as described above, and detailed messages beingsent (block 974) to a sterilizing cabinet (150) or record server as maybe appropriate. Once the sterilization cycle is complete, the biologicalindicator may be removed from the sterilizing cabinet (150) andtransported to the indicator analyzer (800) where it may be scanned(block 948) and inserted for analysis (block 952) as has been describedabove. Once analysis is complete, notifications may be generated and theresults printed (block 976) on whichever device is being treated as amaster device for that particular implementation.

VII. EXEMPLARY COMBINATIONS

The following examples relate to various non-exhaustive ways in whichthe teachings herein may be combined or applied. It should be understoodthat the following examples are not intended to restrict the coverage ofany claims that may be presented at any time in this application or insubsequent filings of this application. No disclaimer is intended. Thefollowing examples are being provided for nothing more than merelyillustrative purposes. It is contemplated that the various teachingsherein may be arranged and applied in numerous other ways. It is alsocontemplated that some variations may omit certain features referred toin the below examples. Therefore, none of the aspects or featuresreferred to below should be deemed critical unless otherwise explicitlyindicated as such at a later date by the inventors or by a successor ininterest to the inventors. If any claims are presented in thisapplication or in subsequent filings related to this application thatinclude additional features beyond those referred to below, thoseadditional features shall not be presumed to have been added for anyreason relating to patentability.

Example 1

A system, comprising: (a) a sterilizing cabinet comprising a sterilizingchamber and a user interface; (b) a biological indicator analyzercomprising at least one biological indicator receiver; and (c) avariable resistance biological indicator comprising: (i) a set ofreadable indicators, the set of readable indicators comprising a firstreadable indicator and a second readable indicator, (ii) an indicatorwindow, and (iii) an adjustable portion operable to selectively movebetween selected vent positions from a set of vent positions, the set ofvent positions comprising a first vent position and a second ventposition, wherein each readable indicator of the set of readableindicators is associated with a corresponding vent position of the setof vent positions, wherein the adjustable portion is configured toposition first readable indicator in the indicator window when theadjustable portion is in the first vent position; wherein the biologicalindicator analyzer is configured to detect one or more microorganisms inthe biological indicator; wherein the sterilizing cabinet is configuredto execute instructions to verify, based upon the first readableindicator, that the first vent position is compatible with a selectedsterilization cycle before the selected sterilization cycle begins.

Example 2

The system of Example 1, wherein the adjustable portion of the variableresistance biological indicator comprises an inner layer and an outerlayer; wherein the adjustable portion comprises a rotatable portion;wherein the indicator window is positioned on the outer layer; whereinthe set of readable indicators are fixed to the inner layer; wherein theinner layer remains in a fixed position relative to the outer layer whenthe rotatable portion is rotated; wherein the indicator window ispositioned so that at most one readable indicator is within theindicator window at any time.

Example 3

The system of Example 2, wherein the adjustable portion comprises a capof the variable resistance biological indicator.

Example 4

The system of any one or more of Examples 2 through 3, wherein theadjustable portion comprises a housing of the variable resistancebiological indicator.

Example 5

The system of any one or more of Examples 1 through 4, wherein the userinterface comprises a touch screen display; wherein the sterilizingcabinet further comprises a machine readable indicator scanner, whereinthe machine readable indicator scanner comprises a type selected fromthe group consisting of a barcode scanner, a data matrix code scanner, aQR code scanner, an RFID scanner, and a NFC scanner; wherein eachindicator of the set of readable indicators comprises a type selectedfrom the group consisting of a barcode, a data matrix code, a QR code,an RFID chip, and a NFC chip; wherein the set of indicator datacomprises two or more of: (i) a biological indicator identifier, (ii) abiological indicator expiration date, (iii) a biological indicatormanufacturer, (iv) a biological indicator cycle type and vent position,or (v) a previous use indicator.

Example 6

The system of any one or more of Examples 1 through 5, wherein thebiological indicator analyzer further comprises an analyzer scanner,wherein the sterilizing cabinet is further configured to, after thestart of a sterilization cycle, execute instructions to: (i) provide acycle start record to the biological indicator analyzer, and (ii) afterthe sterilization cycle is complete, provide a biological indicatorreminder to the user; and wherein the biological indicator analyzer isconfigured to execute instructions to: (i) capture the set of indicatordata from the first readable indicator via the analyzer scanner, (ii)provide an analysis start record to the sterilizing cabinet, (iii)perform an analysis of the variable resistance biological indicator todetermine a result of the sterilization cycle, and (iv) provide theresult to the sterilizing cabinet.

Example 7

The system of any one or more of Examples 1 through 6, wherein thebiological indicator analyzer further comprises an analyzer scanner,wherein the sterilizing cabinet is further configured to, after thestart of a sterilization cycle, execute instructions to (i) provide acycle start record to the biological indicator analyzer, and (ii) afterthe sterilization cycle is complete, provide a biological indicatorreminder to the user and provide a cycle completion record to thebiological indicator analyzer; and wherein the biological indicatoranalyzer is configured to execute instructions to: (i) capture the setof indicator data from the first readable indicator via the analyzerscanner, and (ii) perform an analysis of the variable resistancebiological indicator to determine a result of the sterilization cycle.

Example 8

The system of any one or more of Examples 1 through 7, wherein thesterilizing cabinet further comprises a readable indicator scanner,wherein the readable indicator scanner comprises a passive tagcommunicator; wherein the variable resistance biological indicatorcomprises an electromagnetic shield layer, wherein the electromagneticshield layer is configured to mitigate communication between the passivetag communicator and every readable indicator of the set of readableindicators not within the indicator window; wherein the biologicalindicator analyzer further comprises an analyzer passive tagcommunicator; wherein the sterilizing cabinet is further configured to,after completing a sterilization cycle, execute instructions to store acycle completion record on a memory of the first readable indicatorusing the passive tag communicator; wherein the biological indicatoranalyzer is configured to execute instructions to: (i) capture the setof indicator data from the first readable indicator via the analyzerpassive tag communicator, (ii) capture the cycle completion record fromthe first readable indicator via the analyzer passive tag communicator,and (iii) perform an analysis of the variable resistance biologicalindicator to determine a result of the sterilization cycle.

Example 9

The system of any one or more of Examples 1 through 8, furthercomprising a record server, wherein the biological indicator analyzerfurther comprises an analyzer scanner, wherein the sterilizing cabinetis further configured to, after the start of a sterilization cycle,execute instructions to: (i) provide a cycle start record to thebiological indicator analyzer, and (ii) after the sterilization cycle iscomplete, provide a biological indicator reminder to the user andprovide a cycle completion record to the record server; and wherein thebiological indicator analyzer is configured to execute instructions to:(i) capture the set of indicator data from the first readable indicatorvia the analyzer scanner, (ii) perform an analysis of the variableresistance biological indicator to determine a result of thesterilization cycle, and (iii) provide the result to the record server.

Example 10

The system of any one or more of Examples 1 through 9, wherein thesterilizing cabinet further comprises a biological indicator holder anda biological indicator adjustor, wherein the biological indicatoradjustor is operable to selectively adjust the adjustable vent of abiological indicator held by the biological indicator holder; whereinthe sterilizing cabinet is further configured to execute instructionsto, when the selected sterilization cycle is not within the set ofsupported sterilization cycles: (i) determine a second vent positionassociated with a second set of supported sterilization cycles, whereinthe selected sterilization cycle is within the second set of supportedsterilization cycles, (ii) operate the adjustable vent of the variableresistance biological indicator to the second vent position, and (iii)begin the selected sterilization cycle.

Example 11

The system of any one or more of Examples 1 through 10, wherein thesterilizing cabinet is further configured to execute instructions toonly begin the selected sterilization cycle when the set of indicatordata indicates that: (i) the variable resistance biological indicator isnot expired, and (ii) the variable resistance biological indicator isfrom an approved manufacturer.

Example 12

The system of any one or more of Examples 1 through 11, wherein thesterilizing cabinet further comprises a readable indicator scanner,wherein the readable indicator scanner comprises a passive tagcommunicator; wherein the passive tag communicator is positioned to scanthe contents of the sterilizing chamber; and wherein the sterilizingcabinet is further configured to execute instructions to: (i) capture aset of indicator data from the first readable indicator via the readableindicator scanner automatically after the variable resistance biologicalindicator is placed within the sterilizing chamber, (ii) determine ifthe variable resistance biological indicator has been used in a previoussterilization cycle based upon the set of indicator data, (iii) onlybegin the selected sterilization cycle when the variable resistancebiological indicator has not been used in a previous sterilizationcycle, and (iv) after the selected sterilization cycle begins, updatethe set of indicator data on the first readable indicator via thepassive tag communicator to reflect that the variable resistancebiological indicator has been used in a previous sterilization cycle.

Example 13

The system of Example 12, wherein the sterilizing cabinet is notcommunicatively coupled with another device over a network.

Example 14

The system of any one or more of Examples 1 through 13, wherein thesterilizing cabinet further comprises a readable indicator scanner,wherein the instructions to verify that the first vent position iscompatible with a selected sterilization cycle before the selectedsterilization cycle begins comprise instructions that, when executed,cause the sterilizing cabinet to: (i) capture a set of indicator datafrom the first readable indicator via the readable indicator scanner,(ii) determine that the variable resistance biological indicator is atthe first vent position based upon the set of indicator data, (iii)identify a set of supported sterilization cycles that are associatedwith the first vent position, (iv) receive, from a user via the userinterface, the selected sterilization cycle, (v) when the selectedsterilization cycle is within the set of supported sterilization cycles,begin the selected sterilization cycle, and (vi) when the selectedsterilization cycle is not within the set of supported sterilizationcycles, provide an indication that the selected sterilization cycle isnot within the set of supported sterilization cycles.

Example 15

The system of Example 14, wherein the set of indicator data isencrypted, and wherein the sterilizing cabinet is further configured toexecute instructions to decrypt the set of indicator data.

Example 16

A method comprising the steps: (a) capturing a set of indicator datarelating to a vent position of a variable resistance biologicalindicator via a sterilizing cabinet; (b) determining, via thesterilizing cabinet, that the variable resistance biological indicatoris at a first vent position based upon the set of indicator data; (c)identifying a set of supported sterilization cycles that are associatedwith the first vent position; (d) receiving the variable resistancebiological indicator in a sterilizing chamber of the sterilizingcabinet; (e) receiving a selected sterilization cycle via a userinterface of the sterilizing cabinet; and (f) either: (i) when theselected sterilization cycle is within the set of supportedsterilization cycles, beginning the selected sterilization cycle, or(ii) when the selected sterilization cycle is not within the set ofsupported sterilization cycles, providing an indication that theselected sterilization cycle is not within the set of supportedsterilization cycles; wherein the variable resistance biologicalindicator comprises an indicator window, an adjustable portion, and atleast two vent indicators, and wherein the adjustable portion is adaptedto be adjusted to a first position which causes the first vent indicatorto be detectable through the indicator window and causes the variableresistance biological indicator to be in the first vent position.

Example 17

The method of Example 16, further comprising the steps: (a) afterbeginning a sterilization cycle, providing a cycle start record from thesterilizing cabinet to a biological indicator analyzer; (b) aftercompleting the sterilization cycle, providing a biological indicatorreminder; (c) at the biological indicator analyzer, capturing the set ofindicator data from the first readable indicator via an analyzer scannerof the biological indicator analyzer; (d) providing an analysis startrecord from the biological indicator analyzer to the sterilizingcabinet; (e) performing an analysis of the variable resistancebiological indicator to determine a result of the sterilization cycle;and (f) providing the result to the sterilizing cabinet.

Example 18

The method of any one or more of Examples 16 through 17, furthercomprising the steps: (a) after completing a sterilization cycle,storing a cycle completion record on a memory of the first readableindicator via a passive tag communicator; (b) capturing the set ofindicator data from the first readable indicator via the passive tagcommunicator; (c) capturing the cycle completion record from the firstreadable indicator via the passive tag communicator; and (d) performingan analysis of the variable resistance biological indicator to determinea result of the sterilization cycle.

Example 19

The method of any one or more of Examples 16 through 18, wherein the setof indicator data is captured automatically after the variableresistance biological indicator is placed within the sterilizingchamber, the method further comprising: (a) determining if the variableresistance biological indicator has been used in a previoussterilization cycle based upon the set of indicator data; (b) onlybeginning the selected sterilization cycle when the variable resistancebiological indicator has not been used in a previous sterilizationcycle; and (c) after beginning the selected sterilization cycle,updating the set of indicator data on the first readable indicator via apassive tag communicator to reflect that the variable resistancebiological indicator has been used in a previous sterilization cycle.

Example 20

A system comprising: (a) a sterilizing cabinet comprising a sterilizingchamber, a user interface, and a first tag communicator; (b) abiological indicator analyzer comprising at least one biologicalindicator receiver and a second tag communicator, wherein thesterilizing cabinet and the biological indicator analyzer are notcommunicatively coupled by a network; and (c) a means for adjusting theresistance of a biological indicator and transporting informationbetween devices.

VIII. MISCELLANEOUS

It should be appreciated that any patent, publication, or otherdisclosure material, in whole or in part, that is said to beincorporated by reference herein is incorporated herein only to theextent that the incorporated material does not conflict with existingdefinitions, statements, or other disclosure material set forth in thisdisclosure. As such, and to the extent necessary, the disclosure asexplicitly set forth herein supersedes any conflicting materialincorporated herein by reference. Any material, or portion thereof, thatis said to be incorporated by reference herein, but which conflicts withexisting definitions, statements, or other disclosure material set forthherein will only be incorporated to the extent that no conflict arisesbetween that incorporated material and the existing disclosure material.

Having shown and described various embodiments of the present invention,further adaptations of the methods and systems described herein may beaccomplished by appropriate modifications by one of ordinary skill inthe art without departing from the scope of the present invention.Several of such potential modifications have been mentioned, and otherswill be apparent to those skilled in the art. For instance, theexamples, embodiments, geometrics, materials, dimensions, ratios, steps,and the like discussed above are illustrative and are not required.Accordingly, the scope of the present invention should be considered interms of the following claims and is understood not to be limited to thedetails of structure and operation shown and described in thespecification and drawings. Instead, the protection should be understoodto be defined by the claims, if any, set forth herein or in the relevantrelated document when the terms in those claims which are listed belowunder the label “Explicit Definitions” are given the explicitdefinitions set forth therein, and the remaining terms are given theirbroadest reasonable interpretation as shown by a general purposedictionary.

To the extent that the interpretation which would be given to suchclaims based on the above disclosure is in any way narrower than theinterpretation which would be given based on the “Explicit Definitions”and the broadest reasonable interpretation as provided by a generalpurpose dictionary, the interpretation provided by the “ExplicitDefinitions” and broadest reasonable interpretation as provided by ageneral purpose dictionary shall control, and the inconsistent usage ofterms in the specification or priority documents shall have no effect.For flowcharts or step diagrams that are shown or described as beingserial, it should be understood that the steps may instead be performedin parallel unless such an implementation is specifically disclaimed orinherently impossible due to stated dependencies. Likewise, anyflowchart or step diagram that is shown or described as being parallelmay instead be performed in series or in sequence, unless such animplementation is specifically disclaimed or inherently impossible dueto stated dependencies. When used in the figures and written descriptionthe terms select, selection, selected, and other variations may notrefer to specific technologies, database syntax, or programminglanguages, and instead refer to a more general process of querying,searching, or identifying a matching or partially matching data set froma larger pool of data.

Explicit Definitions

When appearing in the claims, a statement that something is “based on”something else should be understood to mean that something is determinedat least in part by the thing that it is indicated as being “based on.”When something is required to be completely determined by a thing, itwill be described as being “based exclusively on” the thing.

When used in the claims, “configured” should be understood to mean thatthe thing “configured” is adapted, designed or modified for a specificpurpose. An example of “configuring” in the context of computers is toprovide a computer with specific data (which may include instructions)which can be used in performing the specific acts the computer is being“configured” to do. For example, installing Microsoft® WORD on acomputer “configures” that computer to function as a word processor,which it does by using the instructions for Microsoft WORD incombination with other inputs, such as an operating system, and variousperipherals (e.g., a keyboard, monitor, etc).

When used in the claims, “determining” should be understood to refer togenerating, selecting, defining, calculating or otherwise specifyingsomething. For example, to obtain an output as the result of analysiswould be an example of “determining” that output. As a second example,to choose a response from a list of possible responses would be a methodof “determining” a response. As a third example, to identify datareceived from an external source (e.g., a microphone) as being a thingwould be an example of “determining” the thing.

When used in the claims, a “means for adjusting the resistance of abiological indicator transporting information between devices” should beunderstood as a limitation set forth in the form of a means forperforming a specified function as provided for in the sixth paragraphof 35 U.S.C. § 112 in which the specified function is adjusting theresistance of a biological indicator and transporting informationbetween devices as described in FIG. 12 and its related discussion, andthe corresponding structure is a system having physical components suchas biological indicators shown in FIGS. 7A-7B, and 8A-8C, and theirrelated discussions.

When used in the claims, a “set” should be understood to refer to acollection containing zero or more objects of the type that it refersto. So, for example, a “set of integers” describes an object configuredto contain an integer value, which includes an object that containsmultiple integer values, an object that contains only a single integervalue, and an object that contains no integer value whatsoever.

We claim:
 1. A system comprising: (a) a sterilizing cabinet comprising asterilizing chamber, a user interface, and a first tag communicator; (b)a biological indicator analyzer comprising at least one biologicalindicator receiver and a second tag communicator, wherein thesterilizing cabinet and the biological indicator analyzer are notcommunicatively coupled by a network; (c) a means for adjusting aresistance of a biological indicator; and (d) a means for transportinginformation between the sterilizing cabinet and the biologicalindicator.
 2. A system, comprising: (a) a sterilizing cabinet comprisinga sterilizing chamber and a user interface; (b) a biological indicatoranalyzer; and (c) a variable resistance biological indicator comprising:(i) a set of readable indicators, the set of readable indicatorscomprising a first readable indicator and a second readable indicator,(ii) an indicator window, and (iii) an adjustable portion operable toselectively move between a selected vent positions from a set of ventpositions, the set of vent positions comprising a first vent positionand a second vent position, wherein the first readable indicator isassociated with the first vent position and the second readableindicator is associated with the second vent position, wherein theadjustable portion is configured to position the first readableindicator in the indicator window when the adjustable portion is in thefirst vent position based on a set of indicator data from thesterilizing cabinet; wherein the sterilizing cabinet is configured toidentify a set of supported sterilization cycles associated with thefirst vent position and receive a selected sterilization cycle via theuser interface, and wherein the sterilization cabinet is configured toexecute instructions to verify that the selected sterilization cycle iswithin the set of supported sterilization cycles before the selectedsterilization cycle begins.
 3. The system of claim 2, wherein ananalyzer scanner of the biological indicator analyzer is configured tocapture the set of indicator data from the first readable indicatorafter the completion of a sterilization cycle, and wherein thebiological indicator analyzer is configured to provide the result of thesterilization cycle to the sterilizing cabinets based on the set ofindicator data from the first readable indicator.
 4. The system of claim2, further comprising a passive tag communicator configured to store acycle completion record on a memory of the first readable indicatorafter a sterilization cycle ends, wherein the passive tag communicatoris further configured to capture the set of indicator data from thefirst readable indicator and the cycle completion record, and whereinthe variable resistance biological indicator is analyzed to determine aresult of the sterilization cycle.
 5. A system, comprising: (a) asterilizing cabinet comprising a sterilizing chamber and a userinterface; (b) a biological indicator analyzer comprising at least onebiological indicator receiver; and (c) a variable resistance biologicalindicator comprising: (i) a set of readable indicators, the set ofreadable indicators comprising a first readable indicator and a secondreadable indicator, (ii) an indicator window, and (iii) an adjustableportion operable to selectively move between selected vent positionsfrom a set of vent positions, the set of vent positions comprising afirst vent position and a second vent position, wherein the firstreadable indicator is associated with the first vent position and thesecond readable indicator is associated with the second vent position,wherein the adjustable portion is configured to position the firstreadable indicator in the indicator window when the adjustable portionis in the first vent position; wherein the biological indicator analyzeris configured to detect one or more microorganisms in the variableresistance biological indicator; wherein the sterilizing cabinet isconfigured to execute instructions to verify, based upon the firstreadable indicator, that the first vent position is compatible with aselected sterilization cycle before the selected sterilization cyclebegins.
 6. The system of claim 5, wherein the adjustable portion of thevariable resistance biological indicator comprises an inner layer and anouter layer; wherein the adjustable portion comprises a rotatableportion; wherein the indicator window is positioned on the outer layer;wherein the set of readable indicators are fixed to the inner layer;wherein the inner layer remains in a fixed position relative to theouter layer when the rotatable portion is rotated; wherein the indicatorwindow is positioned so that at most one readable indicator is withinthe indicator window at any time.
 7. The system of claim 6, wherein theadjustable portion comprises a cap of the variable resistance biologicalindicator.
 8. The system of claim 6, wherein the adjustable portioncomprises a housing of the variable resistance biological indicator. 9.The system of claim 5, wherein the user interface comprises a touchscreen display; wherein the sterilizing cabinet further comprises amachine readable indicator scanner, wherein the machine readableindicator scanner comprises a type selected from the group consisting ofa barcode scanner, a data matrix code scanner, a QR code scanner, anRFID scanner, and a NFC scanner; wherein each readable indicator of theset of readable indicators comprises a type selected from the groupconsisting of a barcode, a data matrix code, a QR code, an RFID chip,and a NFC chip; wherein a set of indicator data comprises two or moreof: (i) a biological indicator identifier, (ii) a biological indicatorexpiration date, (iii) a biological indicator manufacturer, (iv) abiological indicator cycle type and vent position, or (v) a previous useindicator.
 10. The system of claim 5, wherein the biological indicatoranalyzer further comprises an analyzer scanner, wherein the sterilizingcabinet is further configured to, after the start of a sterilizationcycle, execute instructions to: (i) provide a cycle start record to thebiological indicator analyzer, and (ii) after the sterilization cycle iscomplete, provide a biological indicator reminder to a user; and whereinthe biological indicator analyzer is configured to execute instructionsto: (i) capture a set of indicator data from the first readableindicator via the analyzer scanner, (ii) provide an analysis startrecord to the sterilizing cabinet, (iii) perform an analysis of thevariable resistance biological indicator to determine a result of thesterilization cycle, and (iv) provide the result to the sterilizingcabinet.
 11. The system of claim 5, wherein the biological indicatoranalyzer further comprises an analyzer scanner, wherein the sterilizingcabinet is further configured to, after the start of a sterilizationcycle, execute instructions to: (i) provide a cycle start record to thebiological indicator analyzer, and (ii) after the sterilization cycle iscomplete, provide a biological indicator reminder to a user and providea cycle completion record to the biological indicator analyzer; andwherein the biological indicator analyzer is configured to executeinstructions to: (i) capture a set of indicator data from the firstreadable indicator via the analyzer scanner, and (ii) perform ananalysis of the variable resistance biological indicator to determine aresult of the sterilization cycle.
 12. The system of claim 5, whereinthe sterilizing cabinet further comprises a readable indicator scanner,wherein the readable indicator scanner comprises a passive tagcommunicator; wherein the variable resistance biological indicatorcomprises an electromagnetic shield layer, wherein the electromagneticshield layer is configured to mitigate communication between the passivetag communicator and every readable indicator of the set of readableindicators not within the indicator window; wherein the biologicalindicator analyzer further comprises an analyzer passive tagcommunicator; wherein the sterilizing cabinet is further configured to,after completing a sterilization cycle, execute instructions to store acycle completion record on a memory of the first readable indicatorusing the passive tag communicator; wherein the biological indicatoranalyzer is configured to execute instructions to: (i) capture a set ofindicator data from the first readable indicator via the analyzerpassive tag communicator, (ii) capture the cycle completion record fromthe first readable indicator via the analyzer passive tag communicator,and (iii) perform an analysis of the variable resistance biologicalindicator to determine a result of the sterilization cycle.
 13. Thesystem of claim 5, further comprising a record server, wherein thebiological indicator analyzer further comprises an analyzer scanner,wherein the sterilizing cabinet is further configured to, after thestart of a sterilization cycle, execute instructions to: (i) provide acycle start record to the biological indicator analyzer, and (ii) afterthe sterilization cycle is complete, provide a biological indicatorreminder to a user and provide a cycle completion record to the recordserver; and wherein the biological indicator analyzer is configured toexecute instructions to: (i) capture a set of indicator data from thefirst readable indicator via the analyzer scanner, (ii) perform ananalysis of the variable resistance biological indicator to determine aresult of the sterilization cycle, and (iii) provide the result to therecord server.
 14. The system of claim 5, wherein the sterilizingcabinet further comprises a biological indicator holder and a biologicalindicator adjustor, wherein the biological indicator adjustor isoperable to selectively adjust the adjustable portion of the variableresistance biological indicator held by the biological indicator holder;wherein the sterilizing cabinet is further configured to executeinstructions to, when the selected sterilization cycle is not within aset of supported sterilization cycles: (i) determine the second ventposition associated with a second set of supported sterilization cycles,wherein the selected sterilization cycle is within the second set ofsupported sterilization cycles, (ii) operate the adjustable portion ofthe variable resistance biological indicator to the second ventposition, and (iii) begin the selected sterilization cycle.
 15. Thesystem of claim 5, wherein the sterilizing cabinet is further configuredto execute instructions to only begin the selected sterilization cyclewhen a set of indicator data indicates that: (i) the variable resistancebiological indicator is not expired, and (ii) the variable resistancebiological indicator is from an approved manufacturer.
 16. The system ofclaim 5, wherein the sterilizing cabinet further comprises a readableindicator scanner, wherein the readable indicator scanner comprises apassive tag communicator; wherein the passive tag communicator ispositioned to scan the contents of the sterilizing chamber; and whereinthe sterilizing cabinet is further configured to execute instructionsto: (i) capture a set of indicator data from the first readableindicator via the readable indicator scanner automatically after thevariable resistance biological indicator is placed within thesterilizing chamber, (ii) determine if the variable resistancebiological indicator has been used in a previous sterilization cyclebased upon the set of indicator data, (iii) only begin the selectedsterilization cycle when the variable resistance biological indicatorhas not been used in a previous sterilization cycle, and (iv) after theselected sterilization cycle begins, update the set of indicator data onthe first readable indicator via the passive tag communicator to reflectthat the variable resistance biological indicator has been used in aprevious sterilization cycle.
 17. The system of claim 16, wherein thesterilizing cabinet is not communicatively coupled with another deviceover a network.
 18. The system of claim 5, wherein the sterilizingcabinet further comprises a readable indicator scanner, wherein theinstructions to verify that the first vent position is compatible with aselected sterilization cycle before the selected sterilization cyclebegins comprise instructions that, when executed, cause the sterilizingcabinet to: (i) capture a set of indicator data from the first readableindicator via the readable indicator scanner, (ii) determine that thevariable resistance biological indicator is at the first vent positionbased upon the set of indicator data, (iii) identify a set of supportedsterilization cycles that are associated with the first vent position,(iv) receive, from a user via the user interface, the selectedsterilization cycle, (v) when the selected sterilization cycle is withinthe set of supported sterilization cycles, begin the selectedsterilization cycle, and (vi) when the selected sterilization cycle isnot within the set of supported sterilization cycles, provide anindication that the selected sterilization cycle is not within the setof supported sterilization cycles.
 19. The system of claim 18, whereinthe set of indicator data is encrypted, and wherein the sterilizingcabinet is further configured to execute instructions to decrypt the setof indicator data.